Wound treatment apparatuses

ABSTRACT

Methods and apparatuses are disclosed relating to the creation and use of bespoke wound fillers and other wound treatment apparatuses. Some embodiments provide for the creation of bespoke wound fillers based on characteristics of a wound. Certain embodiments also include the use of bespoke wound fillers in combination with negative pressure to treat a wound.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S Provisional Application No.61/929,864, filed Jan. 21, 2014, and entitled BESPOKE WOUND TREATMENTAPPARATUSES AND METHODS FOR USE IN NEGATIVE PRESSURE WOUND THERAPY. Thecontent of the aforementioned application is hereby incorporated byreference in its entirety as if fully set forth herein. The benefit ofpriority to the foregoing application is claimed under the appropriatelegal basis, including, without limitation, under 35 U.S.C. § 119(e).

BACKGROUND OF THE INVENTION Field of the Invention

Embodiments described herein relate to wound fillers, in particularwound fillers for use with negative pressure wound therapy, and that maybe fabricated or created in a bespoke or custom manner for use in woundtreatment.

Description of the Related Art

Wound fillers, especially for use in negative pressure therapy, play acritical role in wound treatment. Nevertheless, sizing wound fillers foruse in a wound can be difficult, time consuming, and imperfect,especially for irregularly-shaped wounds.

SUMMARY OF THE INVENTION

Accordingly, embodiments described herein relate to devices, methods,and systems for providing bespoke or customized wound fillers for thetreatment of a wound. In certain embodiments, a bespoke wound filler isfabricated and optimized for use with negative pressure wound therapy.Preferably, a bespoke wound filler may be created by obtaining athree-dimensional scan or model of a wound, and manufacturing a bespokewound filler configured to be used with the wound.

In certain embodiments, a method of manufacturing a wound filler for usein negative pressure wound therapy may comprise:

creating a three-dimensional model of a wound filler based on athree-dimensional model of a wound space to be treated with negativepressure wound therapy; and

fabricating a bespoke wound filler based on the createdthree-dimensional model of the wound filler, wherein the bespoke woundfiller comprises at least a first plurality of identical repeating cellsconfigured to collapse in a manner determined by the three-dimensionalmodel to account for attributes of the wound and for a negative pressurewound therapy treatment modality.

In some embodiments, an apparatus for treating a wound with negativepressure therapy may comprise a bespoke wound filler comprising at leasta first plurality of identical repeating cells configured to collapse ina manner determined by a three-dimensional model created based on a scanof the wound to account for attributes of the wound and for a negativepressure wound therapy treatment modality, the wound filler having ashape and configuration constructed to custom fit into the wound.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be apparentfrom the following detailed description of the invention, taken inconjunction with the accompanying drawings of which:

FIG. 1 is a schematic illustration of a negative pressure system.

FIG. 2 is a schematic illustration of a wound with irregular margins.

FIG. 3 is a schematic illustration of the wound from FIG. 1 filled withan embodiment of a bespoke wound filler and used in conjunction with anegative pressure treatment system.

FIG. 4 is a schematic illustration of a wound comprising multiple tissuetypes being treated with an embodiment of a bespoke wound filler used inconjunction with a negative pressure treatment system.

FIGS. 5A-C are photographs of an embodiment of a repeating buildingblock that may be used as a bespoke wound filler system.

FIGS. 6A-D illustrate different views of embodiments of a wound closuredevice comprising a stabilizing structure.

FIGS. 7A-E illustrate different views and photographs of embodiments ofa wound closure device comprising a stabilizing structure.

FIGS. 8A-B are before and after photographs of experiments performed todetermine the efficacy of certain embodiments of wound closure devices.

FIGS. 9A-B are before and after photographs of experiments performed todetermine the efficacy of certain embodiments of wound closure devices.

FIGS. 10A-B are before and after photographs of experiments performed todetermine the efficacy of certain embodiments of wound closure devices.

FIGS. 11A-E illustrate additional embodiments of a wound closure devicecomprising a stabilizing structure.

FIGS. 12A-C illustrate an embodiment of a stabilizing structuremanufactured from felted foam.

FIGS. 13A-B are photographs of further embodiments of wound closuredevices comprising a porous wound filler material.

FIGS. 14A-B illustrates an additional embodiment of a wound closuredevice comprising a stabilizing structure.

FIG. 15 illustrates an additional embodiment of a wound closure devicecomprising a stabilizing structure.

FIG. 16 illustrates an additional embodiment of a wound closure devicecomprising a stabilizing structure.

FIG. 17 illustrates an additional embodiment of a wound closure devicecomprising a stabilizing structure.

FIG. 18 illustrates an additional embodiment of a wound closure devicecomprising a stabilizing structure.

FIGS. 19A-B illustrate additional embodiments of wound closure devicescomprising a stabilizing structure.

FIGS. 20A-B are before and after photographs of experiments performed todetermine the efficacy of certain embodiments of wound closure devices.

FIGS. 21A-B are before and after photographs of experiments performed todetermine the efficacy of certain embodiments of wound closure devices.

FIG. 22 is a photograph of an experiment performed to determine theefficacy of certain embodiments of wound closure devices.

FIGS. 23A-B are photographs of experiments performed to determine theefficacy of certain embodiments of wound closure devices.

FIGS. 24A-E are photographs of various embodiments of stabilizingstructures comprising inserts disposed therein.

FIGS. 25A-F illustrate various embodiments of inserts that may be usedin stabilizing structures.

FIGS. 26A-F illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 27A-D illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 28A-E illustrate multiple views of an embodiment of a stabilizingstructure.

FIG. 29 schematically illustrates an embodiment of a stabilizingstructure.

FIG. 30A illustrates a top view of an embodiment of an oval shapedstabilizing structure.

FIG. 30B illustrates a top view of an embodiment of an oval shapedstabilizing structure with foam.

FIGS. 31A-B illustrate embodiments of methods for closing a wound.

FIGS. 32A-C illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 33A-G illustrate multiple views of an embodiment of a stabilizingstructure.

FIG. 34 illustrates one embodiment of a hinged stabilizing structure forclosing a wound.

FIG. 35 illustrates an embodiment of a fully flexible stabilizingstructure.

FIG. 36 illustrates one embodiment of a stabilizing structure for awound.

FIG. 37 illustrates an embodiment of a stabilizing structure for a woundcut from a roll.

FIG. 38 illustrates an embodiment of a stabilizing structure having anoval shape.

FIGS. 39A-F illustrate multiple views of an embodiment of a stabilizingstructure.

FIGS. 40A-D illustrate multiple views of an embodiment of a stabilizingstructure comprising openings for fluid passage.

FIGS. 41A-C illustrate multiple embodiments of a stabilizing structure.

FIGS. 42A-B illustrate multiple embodiments of a stabilizing structurecomprising windows.

FIGS. 43A-C are photographs of various embodiments of a stabilizingstructure comprising foam inserts.

FIGS. 44A-B illustrate embodiments of a wound filler comprisingstabilizing structures within a porous material.

FIG. 45 illustrates an embodiment of a ring that can surround astabilizing structure.

FIGS. 46A-B are schematic illustrations of embodiments of a woundtreatment apparatus comprising a bespoke wound filler.

FIG. 47 illustrates an embodiment of a repeating building block that maybe part of a bespoke wound.

FIG. 48 illustrates an embodiment of a bespoke wound filler comprising asurrounding lip.

FIGS. 49A-49D illustrates embodiments of securing portions and clipsthat may be constructed as part of a bespoke wound filler.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments disclosed herein relate to apparatuses and methods oftreating a wound, especially with reduced pressure. Embodiments for usewith negative pressure include pump and wound dressing components andapparatuses. The apparatuses and components comprising the wound overlayand packing materials, if any, are sometimes collectively referred toherein as dressings.

It will be appreciated that throughout this specification reference ismade to a wound. It is to be understood that the term wound is to bebroadly construed and encompasses open and closed wounds in which skinis torn, cut or punctured or where trauma causes a contusion, or anyother superficial or other conditions or imperfections on the skin of apatient or otherwise that benefit from reduced pressure treatment. Awound is thus broadly defined as any damaged region of tissue wherefluid may or may not be produced. Examples of such wounds include, butare not limited to, abdominal wounds or other large or incisionalwounds, either as a result of surgery, trauma, sternotomies,fasciotomies, or other conditions, dehisced wounds, acute wounds,chronic wounds, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, burns, electricalburns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, traumaand venous ulcers or the like.

As is used herein, reduced or negative pressure levels, such as −X mmHg,represent pressure levels that are below standard atmospheric pressure,which corresponds to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696psi, etc.). Accordingly, a negative pressure value of −X mmHg reflectsabsolute pressure that is X mmHg below 760 mmHg or, in other words, anabsolute pressure of (760−X) mmHg. In addition, negative pressure thatis “less” or “smaller” than X mmHg corresponds to pressure that iscloser to atmospheric pressure (e.g., −40 mmHg is less than −60 mmHg).Negative pressure that is “more” or “greater” than −X mmHg correspondsto pressure that is further from atmospheric pressure (e.g., −80 mmHg ismore than −60 mmHg).

The negative pressure range for some embodiments of the presentdisclosure can be approximately −80 mmHg, or between about −20 mmHg and−200 mmHg. Note that these pressures are relative to normal ambientatmospheric pressure. Thus, −200 mmHg would be about 560 mmHg inpractical terms. In some embodiments, the pressure range can be betweenabout −40 mmHg and −150 mmHg. Alternatively a pressure range of up to−75 mmHg, up to −80 mmHg or over −80 mmHg can be used. Also in otherembodiments a pressure range of below −75 mmHg can be used.Alternatively, a pressure range of over approximately −100 mmHg, or even150 mmHg, can be supplied by the negative pressure apparatus. In someembodiments, the negative pressure range can be as small as about −20mmHg or about −25 mmHg, which may be useful to reduce fistulas. In someembodiments of wound closure devices described here, increased woundcontraction can lead to increased tissue expansion in the surroundingwound tissue. This effect may be increased by varying the force appliedto the tissue, for example by varying the negative pressure applied tothe wound over time, possibly in conjunction with increased tensileforces applied to the wound via embodiments of the wound closuredevices. In some embodiments, negative pressure may be varied over timefor example using a sinusoidal wave, square wave, and/or insynchronization with one or more patient physiological indices (e.g.,heartbeat). Examples of such applications where additional disclosurerelating to the preceding may be found include application Ser. No.11/919,355, titled “WOUND TREATMENT APPARATUS AND METHOD,” filed Oct.26, 2007, published as US 2009/0306609; and U.S. Pat. No. 7,753,894,titled “WOUND CLEANSING APPARATUS WITH STRESS,” issued Jul. 13, 2010.Both applications are hereby incorporated by reference in theirentirety.

Turning to FIG. 1, treatment of a wound with negative pressure incertain embodiments uses a negative pressure treatment system 101 asillustrated schematically here. In this embodiment, a wound site 110,illustrated here as an abdominal wound site, may benefit from treatmentwith negative pressure. However, many different types of wounds may betreated by such a method, and the abdominal wound illustrated here ismerely one particular example. Such abdominal wound sites may be aresult of, for example, an accident or due to surgical intervention. Insome cases, medical conditions such as abdominal compartment syndrome,abdominal hypertension, sepsis, or fluid edema may require decompressionof the abdomen with a surgical incision through the abdominal wall toexpose the peritoneal space, after which the opening may need to bemaintained in an open, accessible state until the condition resolves.Other conditions may also necessitate that an opening remain open, forexample if multiple surgical procedures are required (possiblyincidental to trauma), or there is evidence of clinical conditions suchas peritonitis or necrotizing fasciitis.

In cases where there is a wound, particularly in the abdomen, managementof possible complications relating to the exposure of organs and theperitoneal space is desired, whether or not the wound is to remain openor if it will be closed. Therapy, preferably using the application ofnegative pressure, can be targeted to minimize the risk of infection,while promoting tissue viability and the removal of deleterioussubstances from the wound site. The application of reduced or negativepressure to a wound site has been found to generally promote fasterhealing, increased blood flow, decreased bacterial burden, increasedrate of granulation tissue formation, to stimulate the proliferation offibroblasts, stimulate the proliferation of endothelial cells, closechronic open wounds, inhibit burn penetration, and/or enhance flap andgraft attachment, among other things. It has also been reported thatwounds that have exhibited positive responses to treatment by theapplication of negative pressure include infected open wounds, decubitusulcers, dehisced incisions, partial thickness burns, and various lesionsto which flaps or grafts have been attached. Consequently, theapplication of negative pressure to a wound site 110 can be beneficialto a patient.

Accordingly, certain embodiments provide for a wound contact layer 105to be placed over the wound site 110. Preferably, the wound contactlayer 105 can be a thin, flexible material which will not adhere to thewound site or the exposed viscera in close proximity. For example,polymers such as polyurethane, polyethylene, polytetrafluoroethylene, orblends thereof may be used. In one embodiment, the wound contact layeris permeable. For example, the wound contact layer 105 can be providedwith openings, such as holes, slits, or channels, to allow the removalof fluids from the wound site 110 or the transmittal of negativepressure to the wound site 110. Additional embodiments of the woundcontact layer 105 are described in further detail below.

Certain embodiments of the negative pressure treatment system 101 mayalso use a wound filler 103, which may be a bespoke wound filler as willbe described in much greater detail below and which can be disposed overthe wound contact layer 105 or into direct contact with the wound. Thewound filler 103 shown in FIG. 1 is merely illustrative of oneconfiguration of a wound filler that may be utilized, wherein portionsof the wound filler may be torn away to appropriately size the woundfiller. In some embodiments, the bespoke wound fillers described ingreater detail below eliminate the need to provide a wound filler thatneeds to be cut or sized by the clinician before applying the woundfiller into the wound. In certain embodiments, the wound filler of anyof the embodiments described herein this section or elsewhere in thespecification is applied directly to the wound with or without a woundcontact layer 105 and/or a drape 107. This filler 103 can be constructedfrom a porous material, for example foam, that is soft, resilientlyflexible, and generally conformable to the wound site 110. Such a foamcan include an open-celled and reticulated foam made, for example, of apolymer. Suitable foams include foams composed of, for example,polyurethane, silicone, and polyvinyl alcohol. In certain embodiments,this filler 103 can channel wound exudate and other fluids throughitself when negative pressure is applied to the wound. Some fillers 103may include preformed channels or openings for such purposes. Otherembodiments of wound fillers that may be used in place of or in additionto the filler 103 are discussed in further detail below.

In some embodiments, a drape 107 is used to seal the wound site 110. Thedrape 107 can be at least partially liquid impermeable, such that atleast a partial negative pressure may be maintained at the wound site.Suitable materials for the drape 107 include, without limitation,synthetic polymeric materials that do not significantly absorb aqueousfluids, including polyolefins such as polyethylene and polypropylene,polyurethanes, polysiloxanes, polyamides, polyesters, and othercopolymers and mixtures thereof. The materials used in the drape may behydrophobic or hydrophilic. Examples of suitable materials includeTranseal® available from DeRoyal and Op Site® available from Smith &Nephew. In order to aid patient comfort and avoid skin maceration, thedrapes in certain embodiments are at least partly breathable, such thatwater vapor is able to pass through without remaining trapped under thedressing. An adhesive layer may be provided on at least a portion theunderside of the drape 107 to secure the drape to the skin of thepatient, although certain embodiments may instead use a separateadhesive or adhesive strip. Optionally, a release layer may be disposedover the adhesive layer to protect it prior to use and to facilitatehandling of the drape 107; in some embodiments, the release layer may becomposed of multiple sections.

The negative pressure system 101 can be connected to a source ofnegative pressure, for example a pump 114. One example of a suitablepump is the Renasys EZ pump available from Smith & Nephew. The drape 107may be connected to the source of negative pressure 114 via a conduit112. The conduit 112 may be connected to a port 113 situated over anaperture 109 in the drape 107, or else the conduit 112 may be connecteddirectly through the aperture 109 without the use of a port. In afurther alternative, the conduit may pass underneath the drape andextend from a side of the drape. U.S application Ser. No. 10/533,275,filed Oct. 28, 2003, titled “APPARATUS FOR ASPIRATING, IRRIGATING, ANDCLEANSING WOUNDS,” issued as U.S. Pat. No. 7,524,315 discloses othersimilar aspects of negative pressure systems and is hereby incorporatedby reference in its entirety. All references in this application thatare incorporated in their entireties should be considered as if fullyset forth herein.

In many applications, a container or other storage unit 115 may beinterposed between the source of negative pressure 114 and the conduit112 so as to permit wound exudate and other fluids removed from thewound site to be stored without entering the source of negativepressure. Certain types of negative pressure sources—for example,peristaltic pumps—may also permit a container 115 to be placed after thepump 114. Some embodiments may also use a filter to prevent fluids,aerosols, and other microbial contaminants from leaving the container115 and/or entering the source of negative pressure 114. Furtherembodiments may also include a shut-off valve or occluding hydrophobicand/or oleophobic filter in the container to prevent overflow; otherembodiments may include sensing means, such as capacitive sensors orother fluid level detectors that act to stop or shut off the source ofnegative pressure should the level of fluid in the container be nearingcapacity. At the pump exhaust, it may also be preferable to provide anodor filter, such as an activated charcoal canister. In furtherembodiments, the aforementioned wound treatment system may be combinedwith a fluid source to allow for irrigation of the wound.

In other embodiments, a negative pressure wound therapy apparatus mayutilize a canister-less system, such as the PICO system available fromSmith & Nephew. In some embodiments, a wound dressing may be providedcomprising an absorbent layer such as a superabsorbing materialconfigured to store wound exudate therein. The absorbent layer may becontained between a wound cover or backing layer and an optional woundcontact layer, and the entire dressing may include a port configured tobe connected to a source of negative pressure. Such dressings mayinclude multiple layers configured to facilitate transmission ofnegative pressure to a wound site and also to promote flow of fluid intothe absorbent layer. Further details regarding wound treatmentapparatuses and methods incorporating absorbent materials, transmissionlayers and other components are found in U.S. application Ser. No.10/575,871, filed Jan. 29, 2007, titled “WOUND CLEANSING APPARATUSIN-SITU,” issued as U.S. Pat. No. 7,964,766; U.S. application Ser. No.12/744,055, filed May 20, 2010, titled “VACUUM ASSISTED WOUND DRESSING,”published as US2011/0009838; U.S. application Ser. No. 12/744,277, filedSep. 20, 2010, titled “WOUND DRESSING,” published as US2011/0028918;U.S. application Ser. No. 12/744,218, filed Sep. 20, 2010, titled “WOUNDDRESSING,” published as US2011/0054421; U.S. application Ser. No.13/092,042, filed Apr. 21, 2011, titled “WOUND DRESSING AND METHOD OFUSE,” published as US2011/0282309; U.S. application Ser. No. 11/432,855,filed May 11, 2006, titled “DEVICE AND METHOD FOR WOUND THERAPY,” issuedas U.S. Pat. No. 7,615,036; U.S. application Ser. No. 11/610,458, filedDec. 13, 2006, titled “DEVICE AND METHOD FOR WOUND THERAPY,” issued asU.S. Pat. No. 7,779,625; U.S. application Ser. No. 12/592,049, filedNov. 18, 2009, titled “DEVICE AND METHOD FOR WOUND THERAPY,” issued asU.S. Pat. No. 8,460,255; PCT Application No. PCT/US13/53075, filed Jul.31, 2013, titled “WOUND DRESSING AND METHOD OF TREATMENT”; U.S.application Ser. No. 11/517,210, filed Sep. 6, 2006, titled “SELFCONTAINED WOUND DRESSING WITH MICROPUMP,” issued as U.S. Pat. No.7,569,742; U.S. application Ser. No. 11/516,925, filed Sep. 6, 2006,titled “WOUND DRESSING WITH VACUUM RESERVOIR,” issued as U.S. Pat. No.7,699,823; U.S. application Ser. No. 11/516,216, filed Sep. 6, 2006,titled “SELF-CONTAINED WOUND DRESSING APPARATUS,” published asUS2007/0055209; the entireties of each of which are hereby incorporatedby reference.

FIG. 2 illustrates a wound 201 that may require filling with a bespokewound filler so as to appropriately treat and heal the wound.Preferably, the wound 201 will be treated with negative pressure. Themargins and contours of the wound 201 as illustrated are irregular,rendering it difficult to fill the wound with conventional fillers.

FIG. 3 illustrates the wound 201 having a bespoke filler 203 insertedtherein. Preferably, a liquid-impermeable drape 205 is placed over thewound and sealed against skin proximate the wound margins, for examplewith an adhesive. An aperture 206 may be made into the drape 205 so asto provide a fluidic connection to a source of negative pressure (notillustrated) such as a vacuum pump. Preferably, the aperture 206communicates with a fluidic connector or port 207, which may be attachedto the source of negative pressure via a conduit 208. Further detailsregarding negative pressure systems, apparatuses and methods that may beutilized with the systems, apparatuses and methods described herein arefound in U.S. application Ser. No. 13/381,885, filed Dec. 30, 2011,titled “APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY,”published as US2012/0116334; U.S. application Ser. No. 12/886,088, filedSep. 20, 2010, titled “SYSTEMS AND METHODS FOR USING NEGATIVE PRESSUREWOUND THERAPY TO MANAGE OPEN ABDOMINAL WOUNDS,” published asUS2011/0213287; U.S. application Ser. No. 13/092,042, filed Apr. 21,2011, titled “WOUND DRESSING AND METHOD OF USE,” published asUS2011/0282309; the entireties of each of which are hereby incorporatedby reference.

FIG. 4 illustrates an example of a bespoke wound filler 203 used inconjunction with a wound 201. A drape 205 is placed over the wound 201and sealed (e.g., using an adhesive) against the surrounding skin nearthe wound margins. Preferably, an aperture 206 through the drape 205communicates with a source of negative pressure (not illustrated), and aport 207 may be used as a fluidic connector between the wound and thesource of negative pressure. A conduit 208 may communicate with thesource of negative pressure and the wound. Unlike FIG. 3, the wound 201in FIG. 4 comprises different tissue anatomy, including exposed boneareas 212, in addition to soft tissue areas 214. Of course, other tissuetypes may be present, including for example muscles, nerves, ligaments,tendons, or any other tissue that may become exposed within a wound.According to some embodiments described herein this section and ingreater detail below, the bespoke wound filler 203 is customized to thesize and environment of the wound 201. The wound filler 203 illustratedhere therefore comprises a first contacting area 222 configured tocontact the exposed bone areas 212 and a second contacting area 224configured to contact the soft tissue areas 214. In some embodiments,the first contacting area 222 may be occlusive, substantiallyfluid-impermeable, or have few to no pores , so as to limit the amountof fluid removed from and negative pressure applied to, the exposed bonearea 212. In some embodiments, conversely, the second contacting area224, when configured to contact the soft tissue areas 214, may beconfigured to be porous so as to enhance fluid removal and granulationtissue growth upon application of negative pressure. In someembodiments, the interior body 226 of the bespoke wound filler 203 maybe of a different porosity than other areas; preferably, it comprises amaterial with greater porosity or larger pores than the wound-contactingsurfaces. Such configurations may be preferable to enhance fluidremoval, because, since the larger pores are not in contact with thewound 101, granulation tissue from the wound 101 will not grow into thelarger pores.

In certain embodiments, it may be desirable to limit granulation tissueformation while still allowing fluid to be drawn away via very fineholes or slits. For example, holes or slits may have a diameter of atmost about 0.1 μm, 0.5 μm, 1 μm, 2 μm, 5 μm, 10 μm, 15 μm, 20 μm, 30 μm,40 μm, 50 μm, 75 μm, 100 μm, 125 μm, 150 μm, 175 μm, or 200 μm. Suitablematerials for contacting tissue and maintaining porosity may includeElastollan (from BASF) or other materials as described herein thissection or elsewhere in the specification. Further suitable materialsinclude thermoplastic polyurethanes that are generally non-toxic andsuitable for wound fillers.

Generally, the bespoke filler 203 may be constructed so as to provide abespoke or custom fit into a wound 201. As will be described in greaterdetail below, various attributes of the bespoke filler may be modified,including its dimensions, density, material characteristics (includingthe use of multiple materials), physical characteristics, chemicalcharacteristics, molecular delivery mechanisms, structuralcharacteristics, and other attributes. In some embodiments, portions ofthe bespoke wound filler may have characteristics favorable to theapplication of negative pressure. In certain embodiments, the bespokewound filler may have characteristics that are favorable to theapplication of irrigation.

Generating a 3D Scan of a Wound

The general shape and configuration of the bespoke filler 203 ispreferably determined in relation to the shape and volume of the wound201. The shape and volume of the wound 201 may be determined by anysuitable method, but is preferably done by creating a three-dimensional(3D) scan of the wound 201. Although reference to 3D scans and/or 3Dmodeling is made herein this section and throughout the specification,2D scanning or 2D modeling may also be used in place of the 3D scansand/or 3D models.

Preferably, a device capable of obtaining a 3D scan of the wound 201 isused that does not make contact with the wound. Such devices includelaser scanners (particularly laser scanners employing triangulationtechniques), stereo-optical scanners, or cameras with depth sensors suchas those used in the Microsoft XBOX Kinect®. Other suitable devicesinclude 3D Systems' ZScanner® 800. Preferably, the 3D scan device iscapable of scanning a wound to an accuracy of at least about: 1 μm, 5μm, 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 80 μm, or100 μm. In some embodiments, other methods of obtaining a scan may beused such as deriving a scan from an analog or digital image of thewound.

3D scans may also be generated via CT or MRI images, for example by“stacking” multiple images together to form a 3D model. In certainembodiments, devices that contact the wound (e.g., via a pressuresensitive stylus), may also be used. In other embodiments, physicalmolds of the wound may be used to create a 3D scan. These physical moldsmay be fabricated from any suitable material such as Jeltrate or otheralginate or silicone based materials often used for taking dentalimpressions.

In some embodiments, the tissue is stained with various markers that canbe used to generate a more accurate 3D model. For example, the wound maybe stained with markers that identify particular cell types that may bepresent at the wound site such as the various host cells of the patientor bacterial cells. Cell markers may give an improved overallunderstanding of the wound by indicating the different stages of healingof various areas of the wound or by providing information relating toinfection. Additional markers may be used to stain extra-cellular matrixproteins, thus providing information about the surrounding structure andstate of healing in the wound. Stained tissue can be imaged and analyzedvia any suitable imaging technique, such as fluorescence microscopy orother techniques. However, imaging of a stained wound is not limited tomicroscopic techniques and may be performed via any suitable technique.Preferably, the characteristics data collected from staining the woundmay be incorporated in the 3D model of the wound, matching particularstained areas to particular regions of the model.

Assorted hardware and software necessary to interpret and generate a 3Dscan, and that is usually provided with the devices, may also be used.Such hardware and software may preferably be configured to interfacewith a personal computer. Some embodiments may also provide for aminiaturized and/or self-contained 3D scanning device that comprisesintegrated software and/or hardware.

In some embodiments, the 3D scanning device may be configured tointerface with a telephone or tablet computer. Some embodiments may alsoprovide for a patient to generate a 3D scan themselves (e.g., by using aKinect® sensor), sending or uploading the 3D scan or model to a serviceprovider, and having the service provider create and send a bespokewound filler 203 customized to the patient's particular wound.

Generation of a 3D Model of the Wound Filler

The 3D scanning device will preferably generate a 3D wound model of thevolume of the wound space using appropriate software. Such a 3D woundmodel is then modified to include a 3D model of the appropriate woundfiller. Suitable software includes Solidworks, Solid Edge, and other 3DCAD programs. In certain embodiments, such 3D data sets of the woundsurface volume are generated by subtracting the data set for the woundscan away from a volume larger in overall dimensions than the woundvolume dimensions. Some embodiments may provide for the generation of aninverse of the scan surface volume. The data files generated may be inSTL, STEP, IGES file formats, other 3D model file types, plain textfiles, or any suitable file format. The words “3D model” may begenerally used throughout the specification to describe a 3D model ofthe wound alone, a 3D model of the filler alone, a 3D model of the woundwith filler, or a 3D surface model of the wound surface. In someembodiments, 3D models may include polygonal mesh, voxel, solid bodyfiles, or any other suitable 3D modelling file. The models may beinterchangeable between various formats. For example, when using CT scandata generated as a DICOM (Digital imaging and Communications inMedicine) data set, the tissue structures that form the wound may firstbe selected using a contrast threshold or through manual selection ofparticular tissue structures. In embodiments, the selected tissue maythen be exported into a Mesh file, e.g. STL format. Following tissueselection and exportation, the data may be further filtered and modifiedto, for example: remove/add holes/folds, add/remove surface texturing,smooth the data set, or provide any other suitable modification. A solidbody model may then be generated from this initial modified data mesh.In certain embodiments, this solid body may then be used to subtractfrom a solid body slightly larger than the wound in dimensions to createan exact solid body of the wound void. The use of any of theabove-mentioned types of models is applicable to any of the embodimentsdescribed herein this section and elsewhere in the specification.

Preferably, the software program will modify and/or normalize the 3Dwound model obtained from the 3D scanning device so as to make it usablein 3D printing devices (as described below). For example, the softwareprogram may modify the 3D model to make the mesh manifold, removeinverted normals, and optimize detail sizes, wall thicknesses, andorientations for use in the 3D printing device. Additionally, thesoftware will preferably make the top of the 3D model flush with thesurrounding skin, although in some embodiments, it may be preferable forthe bespoke filler (and consequently, the 3D filler model) to extendabove the skin at least in part.

At this stage, attributes of the 3D model may also be modified toaccount for various factors in the wound environment or to account forparticular treatment modalities. A wound will typically contain multipleregions that may be in different stages of healing. For example, a woundmay have areas that: are exudating heavily, are infected, are bleeding,contain dead/dying tissue, are drying, are inflamed, or in various otherstates. Further, the different areas of the wound may comprise differenttypes of tissue, such as bone, cartilage, blood vessels, skin, fat, orany other organs or tissues. To effectively treat these variable tissuetypes and conditions may require different types of fillers withdifferent physical and chemical characteristics as will be described ingreater detail below.

The use of negative pressure in combination with various wound fillershas been demonstrated to effectively improve wound healing. However,such a combination is most effective when the wound filler is tailoredto most effectively apply negative pressure to a particular type ofwound. For example, as is described herein this section and elsewhere inthe specification, a filler with a desired porosity may allow for anincreased volume of fluid to be drawn from a wound at a greater rate.Additionally, as will be described in greater detail below, woundfillers may be tailored to more effectively deliver irrigant fluid to awound. The fillers may also be tailored to collapse under negativepressure in a manner consistent with the direction of closure of thewound. Further details regarding the collapse of wound fillers undernegative pressure will be described in greater detail below,particularly in relation to wound closure devices and stabilizingstructures of FIGS. 6A-44B. In some embodiments, the wound fillersdescribed above may collapse in any manner described with respect to theclosure devices and stabilizing structures of FIGS. 6A-44B.

In some embodiments, as described elsewhere in the specification,internal manifolds may be 3D printed within the filler to deliver fluidto the wound bed. For example, a port may be printed on the exterior ofthe wound filler configured to connect to bot a suction tube and anirrigant tube. The port may in turn be connected to internal manifoldingthat connects the port to the various surfaces of the wound filler, suchas the surface in contact with tissue. For example, the internalmanifold may connect the port to the bottom surface and or the sidesurfaces. In certain embodiments, the fluid manifold may encompass atleast about 10% of the total volume of the bespoke wound filler, atleast about 20%, at least about 30%, at least about 40%, at least about50%, at least about 60%, at least about 70%, at least about 80%, atleast about 90%, or about 100%.

For example, and as described in further detail below, attributes of the3D model may be modified to account for different tissue types in thewound, such as exposed bone or tendon, and which may require that thewound filler be different from wound filler to be used in the treatmentof epidermal, sub-epidermal, or muscle tissue. FIG. 4, as describedabove, describes such an embodiment.

In some embodiments, a human may assist in the creation of a 3D model,leading to the construction of a bespoke wound filler, by identifyingthe properties of the various regions of the wound. Hereinafter the word“clinician” will be used to describe any human involved in the creationof the filler, however “clinician” is not limited to only medicalpractitioners, but could be a home user, general caregiver, or patient.

The clinician may contribute to the creation of a 3D model for a desiredwound filler by identifying the characteristics of the various regionsof a wound which may be treated with the wound filler, for example whileunder negative pressure. For instance, a clinician may identify areas ashighly exudating, drying, infected, or having any other conditiondescribed herein this section or elsewhere in the specification. Aclinician may further identify the tissue type of the various regions ofthe 3D model. The clinician can identify and define characteristics ofthe wound such as the shape of the wound, severity of the wound,expected closure of the wound, or any other relevant characteristic ofthe wound. The clinician may further identify the fluid modality of aparticular area of a wound, such as by identifying the level of fluidrelease from such a portion of the wound. Additionally, the cliniciancan further identify areas of the wound that would be best served by theapplication of various levels of negative pressure. Further, theclinician may identify areas that would be best served by irrigationand/or the delivery of various molecules. In addition to thecharacteristics already described, a clinician may identify any otherkey characteristics that may influence the healing and closure of awound or impact the health of a patient.

Identification of the characteristics of a wound can be performed in avariety of ways as described herein this section and elsewhere in thespecification. In some embodiments, the wound is assessed by visualinspection of the wound via computer or human recognition. In certainembodiments, the assessment of the wound is completed using chemical,physical, auditory, or energy-based assays or imaging techniques. Infurther embodiments, any suitable identification techniques may be used.

In further embodiments, the clinician may also assess additionalhealth-related factors of the patient and incorporate those factors intothe 3D wound model. For example, the clinician could identify a diabeticpatient, and recognize that their circulation may be compromised. Thus,the wound model could be altered to account for poor circulation. Inother embodiments, a clinician could recognize that a patient may beimmune compromised or have other relevant health conditions that mayaffect wound therapy treatment. The clinician may use thesehealth-related factors to modify the 3D model in any suitable manner. Inother embodiments, instead of or in additional to the clinician'scontribution to the model, the scanning software can automaticallygenerate a 3D model of the wound by automatically identifying theproperties of the various regions of the wound as any of the tissuetypes or characteristics described herein. Additionally, the 3D modelmay be modified automatically by a computer algorithm based on thegeneral health characteristics of the patient. Generally, any taskdescribed herein this section or throughout the specification as to beperformed by a clinician may also be automated to be performed via acomputing or generally automated process.

In some embodiments, the characteristics of the wound can be translatedinto data points that correspond to spatial points within the 3D model.Thus, spatial points of the 3D wound model may have corresponding woundcharacteristic data. Such wound characteristic data then may be used asa basis to modify the wound model to build in a corresponding woundfiller model or to create a separate, independent wound filler model.

As described herein this section and elsewhere in the specification, a3D wound filler model suitable for 3D printing or other custom means offabrication can be generated from the 3D model of the wound. However,the 3D model of a wound filler need not be generated from a 3D model ofa wound. Instead the 3D model of the wound filler can be designedmanually by a clinician with assigned characteristics as needed. Theclinician may use their assessment of the wound to identify and defineparticular regions of the wound filler to correspond withcharacteristics of the wound. In preferred embodiments, the wound filleris designed to facilitate the application of negative pressure to thewound and/or to irrigate the wound. In certain embodiments, theclinician may consider the long term closure of the wound in designatingthe characteristics of the wound filler. For example, the clinician mayconstruct the 3D model with the direction of closure in mind, such as byaligning the closure along the Langer lines or along a shorter axis ofthe wound.

As is described herein this section and elsewhere in the specification,the 3D wound filler model is comprised of various regions that may havevariable physical, chemical, and structural characteristics as isdesired to treat the wound. The physical, chemical, and structuralcharacteristics of the wound filler model can be determined from thecorresponding characteristics of the 3D wound model or via any processas described herein this section or elsewhere in the specification. Insome embodiments, the physical, chemical, and structural characteristicsof the wound filler model can also be assigned. The different regionsmay have significant structural differences or utilize differentmaterials as is appropriate for treatment of a wound. The differentregions may have various chemical properties as is desired for propertreatment of a wound. In preferred embodiments, the different regions ofthe wound filler are tailored for the application of negative pressureas is desired for wound healing. In some embodiments, the 3D woundfiller model is generated automatically based on characteristics of thewound, while in other embodiments the 3D wound filler information isinput manually.

In certain embodiments, a 3D model of the wound filler is created merelyfrom the spatial data contained within the 3D wound model. Such anembodiment may generate a wound filler that accommodates the width,length, and appropriate depth of a wound and could be desirable for thetreatment of an irregularly shaped wound as described above. Inpreferred embodiments, the 3D model of the wound filler is created frommultiple different wound characteristics that were incorporated into the3D model of the wound. The 3D model of the wound filler may also befurther determined by the general health-related characteristics of thepatient.

As described above, in some embodiments, the characteristics of thevarious regions of the wound filler may be determined by the anatomicallocation of the wound and the surrounding tissues. For example, a woundfiller used for the treatment of an abdominal wound may comprise a slitstructure. In another example, a region of a wound filler associatedwith a bone or tendon could be constructed from a hydrophilic materialwith a reasonably closed cell structure so as to maintain moisture inthe surrounding tissue. In some embodiments, a fine pore size in therange of about 10-350μm may be used to maintain moisture. Such a poresize may range from at least about 1 μm, 5 μm, 10 μm, 15 μm, 20 μm, 30μm, 40 μm, 50 μm, 75 μm, 100 μm, 125 μm, 150 μm, 200 μm, 300 μm, 400 μm,500 μm, or more than 500 μm In still another example, the wound fillerregion in the area of a pressure ulcer or highly exudating tissue mayincorporate an open structure such as a reticulated foam so as to betterremove liquid from the tissue. In some embodiments, a larger pore sizein the range of about 350-900 μm may be used to aid in liquid removal.Such a pore size may range widely, for example from at least about 10μm, 50 μm, 100 μm, 200 μm, 300 μm, 400 μm, 500 μm, 1000 μm, 2000 μm,3000 μm, 4000 μm, or 5000 μm. In some embodiments, any of the pore sizesdisclosed in PCT Application No. PCT/GB2012/000489, titled “WOUNDCONTACTING MEMBERS AND METHODS,” filed Jun. 7, 2012, and herebyincorporated by reference in its entirety. Open structures may also beused in areas of the wound where granulation tissue is desired. Forexample, in areas where granulation tissue is desired, the pore size mayrange from at least about 10 μm, 50 μm, 100 μm, 200 μm, 300 μm, 400 μm,500 μm, 1000 μm, 2000 μm, 3000 μm, 4000 μm, or 5000 μm.

In certain embodiments, as described above, characteristics of thevarious regions of the wound filler may be determined automaticallybased on the 3D wound model or could be assigned. In some embodiments,the characteristics may include water/vapor permeability, gaspermeability, absorption capacity, thickness, material type, materialstructure (such as number of layers), thickness/size, presence ofpharmacological additives, color, hydrophobicity/hydrophilicity, or anyother suitable characteristic.

The various regions of the wound filler such as determined by the 3Dwound model may comprise different materials or have differentstructural characteristics. In non-limiting embodiments, regions of thewound filler may be comprised of: various rigid, semi-rigid, or softfoams; various hydrophilic and/or hydrophobic foams; soft, conformable,and preferably resiliently flexible materials such as polymers,including thermoplastics; various biodegradable materials; cellulosematerials, superabsorbers, or other suitable materials. Suitablepolymers include ABS synthetic rubbers, various silicones such asIntegra, polyurethanes such as the Elastollan series Thermoplasticpolyurethane elastomers (TPUs) from BASF and specifically the Elastollanseries hydrophilic TPU, ethylene vinyl acetate, nylons for example Nylon618 from Taulman 3D Missouri, polyamides, and polyethylenes. TheTangoplus family of resins, e.g. Tangoplus FC930, from Stratsys havevarying levels of hardness so that structures with different degrees offlexibility and compression can be fabricated. Further examples ofpossible materials include 3D knit spacer fabrics such as thosemanufactured by Gehring Textiles. In further embodiments, the materialmay comprise polylactic acid (PLA), polyglycolic acid, or any othermaterial disclosed herein this section or elsewhere in thespecification. The wound filler may also include anistropic materialssuch as the coil-like materials found in U.S. Pat. No. 10/981,119, filedNov. 4, 2011, titled “WOUND PACKING MATERIAL FOR USE WITH SUCTION,”issued as U.S. Pat. No. 7,754,937 and hereby incorporated by referencein its entirety and hereinafter referred to as the '937 patent. Thepotential repeating of individual sections of this material is describedin greater detail in the fabrication section below.

As described herein this section and elsewhere in the specification, insome embodiments, the wound filler may have varied structuralcharacteristics such as porosity. In a preferred embodiment, the 3Dprinter (described further below) may control the porosity of theresulting material, either in the bespoke filler as a whole or byvarying the porosity through different sections of the device. Forexample, a wound filler with smaller pores may be preferable to minimizetissue growth or adhesion, while larger pores may be useful to promoteremoval of wound exudate from the wound. Such a configuration may thuscomprise, for example, a material with smaller pores in contact with thewound which encapsulates or is placed underneath a material with largerpores. As described above and elsewhere in the specification, the poresize may vary considerably, such as between about 0.1 to 200 μm.Preferably, smaller pores may measure between about 20 to 150 μm, whilelarger pores may measure between 400-3000 μm or greater. Still otherpores may measure less than about 20 μm, less than about 1 μm, less thanabout 0.5 μm, or between about 150 to 400 μm. In another example,porosity may be reduced in applications where scar tissue (resultingfrom excess granulation tissue) should be minimized. In some cases, thenumber of pores per unit area may be reduced, for example, someembodiments may provide for a wound contacting layer of the bespokewound filler having an open area of approximately 20%, and 1 mm diameterpore sizes. In certain embodiments, other structural characteristics maybe varied within the material, such as to make the material open-celledwith interconnected cavities within the material and/or closed-celled.The structural characteristics of the wound filler are limited only bythe capabilities of the 3D fabrication device, and thus all manner ofstructures and shapes suitable for wound treatment may be used.

In some embodiments, the wound filler is tailored for the application ofnegative pressure. As described above in relation to FIG. 4, andelsewhere in the specification, the wound filler may be designed to havevarious levels of porosity. In some embodiments, the porosity may bevaried to promote liquid flow from portions of the wound via theapplication of negative pressure. To better control the application ofnegative pressure, portions of the bespoke wound filler may be made tocover portions of the anatomy from which minimal or no fluid removal isdesired. For example, some tissue types, such as exposed bone or tendon,may dry out or be adversely impacted due to the application of negativepressure therapy. Manufacturing a bespoke wound filler that has minimalor no pores when placed over such tissue anatomy may thus beadvantageous. Preferably, the bespoke wound filler is manufactured sothat other parts of the tissue anatomy in that same wound that wouldbenefit from a porous wound filler (e.g., epithelial tissue) are incontact with a material that has increased porosity.

In addition to altering the porosity of the wound filler to accommodatethe desired application of negative pressure, the wound filler maycontain flow channels that direct wound exudate drawn via negativepressure. Such flow channels may be oriented horizontally through thewound filler and/or may be oriented vertically. Regions of the fillerwhere limited or no negative pressure is desired may have few if anychannels. In certain embodiments, the material characteristics of thewound filler may also be further tailored to accommodate negativepressure such as by using hydrophobic materials like hydrophobic foam toallow for the application of negative pressure without trapping fluid.In some embodiments, hydrophilic materials may be used to trap woundexudate drawn from the surrounding wound tissues. The hydrophilicmaterials may be superabsorbers. The various regions of the wound fillermay be open celled, closed celled, or a combination of the two as isneeded to apply desired levels of negative pressure. In someembodiments, particular regions of the wound filler may be constructedas wicking layers to wick fluid in a desirable manner. As describedherein this section and elsewhere in the specification, differentregions of the wound filler may have different functions and properties,such that the application of negative pressure to various areas of thewound can be well controlled.

In some embodiments, the bulk of the wound filler comprises open-celledhydrophobic material to allow for fluid flow via the application ofnegative pressure. In certain embodiments, this significant bulk ofopen-celled hydrophobic material may be surrounded by other materialssuited for more direct contact with the wound tissues.

In particular embodiments, as will be described in much greater detailbelow in relation to FIGS. 6A-44B, the wound filler may be tailored tocollapse more readily in one direction than in another direction. Asdescribed elsewhere in the specification, the wound filler may collapsemore readily in a horizontal direction while remaining relatively rigidin the vertical direction. It will be recognized by one of skill in theart that “horizontal direction” may refer to a plane parallel to theplane of the wound, while vertical direction may refer to a planeperpendicular to the plane of the wound. It will further be recognizedby one of skill in the art, that such a wound filler may collapse undernegative pressure horizontally within the wound in a directionperpendicular to the longitudinal axis of the wound, while remainingsubstantially rigid in the vertical direction. In certain embodiments,particular regions of the wound filler may collapse, while other regionsremain rigid.

In some embodiments, the 3D wound filler may be tailored for theapplication of irrigation to the wound. In certain embodiments, thewound filler is connected to one or more reservoirs containing irrigantfluid. Such irrigant fluid may contain antimicrobial molecules,anti-inflammatory molecules, marking molecules, or growth factors thatpromote wound healing. Irrigant fluid may be applied simultaneously withthe application of negative pressure, such that simultaneous irrigationand aspiration is possible. In other embodiments, aspiration thenirrigation or irrigation then aspiration are sequential.

The use of irrigation may be desirable for certain regions of the wound,thus the wound filler may be tailored to best apply irrigation to thoseregions of the wound. For example, in drier areas of the wound or inareas requiring debridement via irrigation, the wound filler may beconfigured to allow greater irrigant flow to the wound. Such anapplication may include wound filler regions comprising flow channels,such as those described above in relation to negative pressure, thatdirect fluid flow towards specific portions of the wound. In otherembodiments, regions of the wound filler directed towards irrigant flowmay be more porous or be open-celled, thus allowing for greater flow ofirrigant fluid. In areas of the wound where irrigation is lessdesirable, portions of the wound filler may be made to be moreocclusive, with smaller or nonexistent pores, or a closed-cellstructure. Such features are applicable to any manifold disclosed hereinthis section or elsewhere in the specification.

In some embodiments, the 3D wound filler model may be constructed suchthat the filler has different layers of material and structure. Forexample, in a penetrating wound, the filler may have layers of softermaterial deeper in the wound, with layers of more rigid material closerto the uppermost surface of the wound, thus allowing for the deeperportions of the wound to close before the portions of the wound that arecloser to the exterior. In some embodiments, the central portion of thefiller may be comprised of one material and/or structure while anexterior portion is comprised of a different material and/or structure.In further embodiments, the wound filler may be layered similar to anonion, with various layers with differing material or structuralproperties surrounding one another. In further embodiments, the layersmay be oriented in a vertical manner such that each layer comprised aflattened section in the horizontal plane.

As described above in relation to the design of the wound filler, FIGS.5A-C illustrate different views of a wound filler 302 which may comprisean anisotropic structure having a first compressive response along afirst axis and a second compressive response along a second axisperpendicular to the first axis, the second compressive response beingdifferent from the first compressive response. In one embodiment, thisstructure may be nonabsorbent, and may comprise stacked, coil-likerepeating units 302. This and other embodiments of wound fillers may bemanufactured by the 3D printer with reference to a 3D model, andexamples of such may be found in the'937 patent, incorporated into thisapplication above. The materials described in the '937 patent haveanisotropic properties, meaning that their material properties may bedimensionally dependent. For example, as described above, an anisotropicmaterial may have increased stiffness in one direction versus anotherdirection. Thus, a material with anisotropic properties such as thosedepicted in the '937 patent may collapse more readily in one directionrather than another. Such a material could be used within the wound tocontrol the compression of the wound filler in particular directions andpreferentially compress the filler to allow for improved wound closure.The material of the '937 patent is nonabsorbent, thus this material mayallow for the passage of negative pressure. In some embodiments, thematerial of '937 may further be used in combination with negativepressure strategies to direct the application of negative pressure andwound closure, in a manner consistent with the embodiments describedherein this section and elsewhere in this specification.

The materials that comprise the wound filler may be determined by thecharacteristics of a particular region of the 3D wound model or may beassigned. For example, an area of the wound that requires additionalhydration could utilize a moist hydrophilic material such as a hydrogel.An area that is highly exudating may need to be highly absorbing andhave a high water vapor evaporation. Areas with low levels of woundexudate may require a nonabsorptive material with low water vaporpermeability so as to trap moisture.

Since a 3D printer is capable of printing a wide variety of shapes, insome embodiments, the 3D model may also include a port and/or tubingsuch that the wound filler may be connected to a source of negativepressure. In further embodiments, the 3D model includes additionalsuitable articles that may be useful for wound healing.

In some embodiments, the material may be configured as a scaffoldmaterial to promote tissue ingrowth and/or bioabsorption. For example,bioabsorption can be achieved by using polyglycolic or polylactic acidsor co-polymers of these polymers, for the printing of the scaffold, andwhich then may be seeded with cells and/or cell growth promoters.Antibiotics, anti-inflammatory drugs, diagnostic agents such asradioopaque markers, and other such materials may also be incorporatedtherein. The scaffold material may be tailored to deliver a variety ofmolecules in the form of controlled delivery. For example, one region ofthe filler could deliver an antimicrobial molecule to an infected regionof tissue, while another region of the filler delivers ananti-inflammatory molecule to an inflamed region of tissue. Variousmolecules may be released in to the surrounding tissue as is merited bythe characteristics of the surrounding tissue. Released molecules arenot limited only to locally acting molecules, in some embodimentssystemically acting drugs may be released.

The wound filler is not limited to one continuous, intact structure. Thewound filler can be constructed to be in separate pieces and appliedseparately to the wound rather than as a single unit. It should beunderstood that all embodiments described herein this section orelsewhere in the specification may be generated as a single continuousstructure or as separate dividable portions. This approach isparticularly useful for dealing with undetermined structures of woundsor tunneling wounds where it may not be possible to insert a singlewound filler

In some embodiments, the wound filler may be constructed as a roundedbowl-like shape, or may comprise a rounded bowl-like shape at the bottomof the filler. This bowl-like shape can be a comprised of a singlematerial layer such as a foam bowl. In certain embodiments, the bowlcomprises one material while a remainder of the wound filler positionedabove or within the bowl comprises a different material. In someembodiments the bowl portion of the filler may be in the form of adivided separate section of the wound filler.

Fabrication of the 3D Wound Filler

Having generated the 3D model, the 3D model can be used by a 3D printingdevice to manufacture the bespoke wound filler. The 3D printing devicemay be any suitable 3D printer, including by means of example only theObjet Connex500™, the 3D Systems ZPrinter® 850, or the RepRap. In otherembodiments, wound filler fabrication may be performed using any knownwound dressing fabrication technique. The wound filler may be fabricatedfrom any materials described herein this section or elsewhere within thespecification, or any other type of suitable material. The wound fillermay be fabricated to comprise any structure described herein thissection or elsewhere within the specification, or any structure that maybe suitable for the wound filler. The wound filler may be fabricated tocomprise any characteristic described herein this section or elsewherewithin the specification, or any characteristic that may be suitable forthe wound filler.

In some embodiments, the wound filler may be fabricated separately fromthe wound and later placed within the wound. In other embodiments, thewound filler may be created directly in the wound. In still otherembodiments, a portion or portions of the wound filler may be createdseparately from the wound, while a portion or portions of the woundfiller may be created directly in the wound.

As described above, the wound filler may be fabricated via any knownfabrication technique. In some embodiments, the wound filler may befabricated via extrusion or via electrospinning techniques. The woundfiller can also be fabricated via gas blowing or localized depositiondirectly into the wound or onto a substrate.

In some embodiments, the outermost or topmost layer of the wound fillercan be comprised of a fluid impermeable polymer, such as silicone. Thisoutermost or topmost layer can overlay the top of the wound filler andextend beyond the edges of the wound. This outermost or topmost layercan further comprise an adhesive or other means for sealing theoutermost layer around the wound. In this manner, the outermost layermay function as a drape to contain the application of negative pressure.In some embodiments this outermost or topmost layer may be fabricated incombination with a biodegradable wound filler such that once the woundfiller biodegrades, the outermost layer is still intact. Similar to theabove description of the materials utilized in the design of the woundfiller, the 3D printer is configured to manufacture a bespoke fillerfrom soft, conformable, and preferably resiliently flexible materialssuch as polymers, including thermoplastics. Suitable polymers includeABS synthetic rubbers, polyurethanes for example Elastollan SP9109 fromBASF, nylons for example Nylon 618 from Taulman3D Missouri, polyamides,ethylenevinyle acetates, and polyethylenes. The Tangoplus family ofresins, e.g. Tangoplus FC930, from Stratsys have varying levels ofhardness so that structures with different degrees of flexibility andcompression can be fabricated. In further embodiments, the materialsutilized to construct the wound filler and other components of the woundtreatment system encompass all materials disclosed in this section andelsewhere in the specification.

As described above in relation to the design of the wound filler, insome embodiments, the 3D printer may be capable of depositing materialsor using materials that form a porous configuration. In someembodiments, the materials may be harder, and may include porousscaffolding materials such as hydroxyapatite that promote tissue growth.The 3D printer may be configured to use multiple materials so as to forma bespoke wound filler composed of multiple devices. In someembodiments, the 3D printer is capable of manufacturing a bespoke woundfiller consisting of a repeating building block, for example thebuilding blocks described herein this section and elsewhere in thespecification.

Some embodiments may also provide for regions of the wound filler to beconstructed from repeating building blocks. The use of repeatingbuilding blocks may be advantageous during manufacture because thesebuilding blocks could be replicated over and over again within the modelallowing for an easier and more efficient creation of structures withinthe filler. Further, the use of building blocks may allow for the 3Dfabrication device and/or the associated software to operate moreefficiently. For example, the use of building blocks may allow thefabrication device to move through tight, specified patterns and limitthe required movement and energy consumption of the device. In someembodiments, the repeating unit may be comprised of any physical,chemical, or structural characteristics as described herein this sectionor elsewhere in the specification. Different regions of the wound fillermay be comprised of different building blocks, allowing for a complexconstruction of layered and/or stacked building blocks of differenttypes. For example, one region comprising a repeating building block mayutilize building blocks of foam having a desired porosity, structure orother characteristics. A second region may comprise repeating buildingblocks made from a different material such as the coil-like materialdescribed in '937 patent and depicted as 302 in FIGS. 5A-C. Based on the3D model, repeating blocks may have different characteristics forpositioning in different parts of the wound. The software for the 3Dprinter or other fabrication device may set the contours of the 3D modelas the limits for a repeating building block and repeat the buildingblock in three dimensions until it reaches the limit of a contour.

Preferably, for small details, the 3D printer can manufacture details ina range of at least about: 0.1 μm, 0.5 μm, 1 μm, 2 μm, 5 μm, 10 μm, 15μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 45 μm, 50 μm, 55 μm, 60 μm, 65μm, 70 μm, 75 μm, 80 μm, 85 μm, 90 μm, 95 μm or 100 μm. Details between30-50 μm may be conducive to obtaining good tissue growth. In someembodiments, the 3D printer is configured to manufacture bespoke woundfillers as detailed in PCT Application PCT/GB2012/000489, filed Jun. 7,2012, titled “WOUND CONTACTING MEMBERS AND METHODS, APPARATUSES, SYSTEMSAND KITS INCORPORATING THE SAME,” published as WO20122168678 and whichis hereby incorporated by reference in its entirety.

With reference to FIG. 47, some embodiments may also provide for thewound filler to be constructed from a repeating building block oridentical cells, for example the building block 502. The 3D fabricationsoftware may thus set the contours of the 3D model as the limits for arepeating building block and repeat the building block in threedimensions until it reaches the limit of a contour. In some embodiments,the repeating building block may be the building block 502, whichpreferably comprises straight sections or walls 504, preferablyconstructed from a rigid polymer, joined together by hinged sections506, preferably constructed from a flexible or soft polymer. Otherembodiments of repeating building blocks or cells may be of any of thestructures wound filler structures described herein this section orelsewhere in the specification. For example, the stabilizing structures,wound closure devices, or other structures described in relation toFIGS. 5A-44B may be used.

In certain embodiments, the wound filler may comprise a singlehorizontal layer of identical cells. In particular embodiments, thewound filler can comprise a plurality of horizontal layers, each layercomprising identical repeating cells. In some embodiments, repeatingcells in a first horizontal layer are different from repeating cells ina second horizontal layer above the first horizontal layer. In someembodiments, the wound filler may comprise a first plurality ofidentical repeating cells and a second plurality of identical repeatingcells, wherein the first plurality of identical repeating cells isdifferent from the second plurality of identical repeating cells. Atleast some of the repeating cells may comprise side walls with anopening extending therethrough, such as shown in FIG. 47. In someembodiments, at least some of the repeating cells can comprise a firstportion with a first stiffness and a second portion with a secondstiffness different from the first stiffness. For example, the firstportion may be an outer portion (such as formed by the walls 504 in FIG.47) surrounding a second portion within the walls 504.

Some embodiments, may call for the bespoke wound filler to comprise aporous material. In any of the embodiments described herein, the bespokewound filler may comprise at least one region comprising a porousmaterial suitable for channeling wound exudate from a wound site andnegative pressure to the wound site, and a more rigid stabilizingstructure at least partially embedded within the porous material.

In some embodiments, the bespoke wound filler may be fabricated from apolymer. In some embodiments, an apparatus such as those describedpreviously, may further comprise a drape configured to be placed overthe bespoke wound filler and be sealed to skin surrounding the wound. Inembodiments, a port may be configured to connect the drape to a sourceof negative pressure. In certain embodiments, a source of negativepressure may be configured to apply negative pressure to the woundfiller under the drape.

Examples of Wound Closure Devices and Stabilizing Structures that May BeUtilized for Bespoke Wound Fillers

Some embodiments may provide for the entirety of or regions of thebespoke wound filler to be constructed with a shape, configuration orincluding components of stabilizing structures and wound closure devicessuch as those described below in relation to FIGS. 6A-44B and 47. Thestabilizing structures and wound closure devices, as described hereinthis section or elsewhere in the specification, may therefore be made asbespoke wound fillers utilizing the methods and apparatuses describedherein. Many of these stabilizing structures and wound closure devicesinclude identical repeating units or cells that may constitute theentirety of or a portion of a desired bespoke wound filler. In at leastsome of these embodiments, the repeating units or cells are configuredto collapse in a desired direction or in a desired manner to facilitateclosure of a wound under negative pressure. The bespoke wound filler maybe designed based on a 3D scan of the wound, the properties of thewound, the negative pressure treatment modality, and/or the manner inwhich the wound is expected or intended to close, to provide for aplurality of repeating cells in certain regions and in a certainorientation within the wound filler.

A bespoke wound filler may also incorporate any of the stabilizingstructures or wound closure devices as described herein, and includeother structures. For example, one region of a bespoke wound filler maycomprise a stabilizing structure and/or wound closure device asdescribed in relation to FIGS. 6A-44B and 47 while another region maycomprise a biodegradable scaffold such as those described above. Thestabilizing structures and wound closure devices described herein thissection or elsewhere in the specification may be incorporated into thebespoke wound filler much like any other region, such as those describedin relation to FIGS. 3-5C. In certain embodiments, different variationsof stabilizing structures and/or wound closure devices may beincorporated within different regions of the same bespoke wound filler.

Some embodiments may call for the entirety of the fabricated woundfiller to be in the form of stabilizing structures and/or wound closuredevices. In particular embodiments, stabilizing structures and/or woundclosure devices may encompass at least about 10% of the total volume ofthe bespoke wound filler, at least about 20%, at least about 30%, atleast about 40%, at least about 50%, at least about 60%, at least about70%, at least about 80%, at least about 90%, or about 100% as describedabove.

Accordingly, in the following description, embodiments of stabilizingstructures and wound closure devices are described, wherein it will beunderstood that such structures and wound closure devices may beutilized or modified to create the entirety of or portions of a bespokewound filler.

Stabilizing Structures and Wound Closure Devices of FIGS. 6A-7E

FIGS. 6A-D illustrate different views of an embodiment of a woundclosure device comprising a stabilizing structure 1701. Here, thestabilizing structure 1701 comprises a first set of beams 1703 that arerigidly or semi-rigidly attached or bonded to a second set ofintersecting beams 1705. These beams 1703, 1705 form a planar supportstructure 1702 that is preferably substantially rigid within a plane.The beams 1703, 1705 may meet at right angles to each other (althoughother configurations, e.g., honeycombs are possible). Two or more planarsupport structures 1702 may be joined together to form the stabilizingstructure 1701, and each planar support structure 1702 is preferablyseparated from the other by spring elements 1711 and 1713, described infurther detail below. The number of planar support structures 1702 usedin the stabilizing structure may be tailored in relation to the size ofthe wound. For example, there may be 2, 3, 4, 5 or more planar supportstructures 1702 arranged parallel or substantially parallel to oneanother. The spring elements 1711, 1713 are preferably arranged so as toallow for compression of the stabilizing structure 1701 in one directionso as to bring the planar support structures 1702 closer together. In apreferred embodiment, the stabilizing structure 1701 may collapse to 40%or less of its original size, preferably 30% or less of its originalsize; more preferably, 20% or less of its original size; even morepreferably, 10% or less of its original size. In some embodiments, thestabilizing structure 1701 may collapse to 5% or less of its originalsize.

The spring elements 1711, 1713 are preferably resiliently flexible andbiased to be resiliently collapsible along a direction perpendicular tothe plane defined by the planar support structure 1702. In someembodiments, the elements 1711, 1713 may be inelastic, and retain theirshape when collapsed. In such embodiments, the spring elements or thestabilizing structure may be constructed with a ratchet mechanism thatmaintains the spring elements 1711, 1713 in their collapsedconfiguration.

In a preferred embodiment, these spring elements 1711, 1713 may be V- orU-shaped. Each spring element may comprise two elongated portions thatare bent relative to each other and form an obtuse angle (as shown inFIGS. 6A-C), or an acute angle (as shown in FIG. 7A). Spring elements1711 preferably run in a plane parallel to beam 1705, and may beattached to either the beam 1703 or 1705. Similarly, spring elements1713 preferably run in a plane parallel to beam 1703, and may beattached to either the beam 1703 or 1705. For both spring elements 1711,1713, a preferred attachment point is at the junction between beams 1703and 1705. Preferably, the spring elements 1711 are arranged in a firstplurality of parallel planes, which run parallel to the direction of thebeam 1705, and the spring elements 1713 are arranged in a secondplurality of parallel planes which run parallel to the direction of thebeam 1703. The spring elements 1711 located between two adjacent planarsupport structures 1702 may be arranged in a repeating pattern withinthe first plurality of parallel planes. The spring elements 1713 locatedbetween two adjacent planar support structures 1702 may be arranged in arepeating pattern within the second plurality of parallel planes. In oneembodiment as illustrated in FIGS. 6A and 6C, adjacent spring elements1711 and 1713 form a diamond shape. However, different patterns,arrangements and numbers of spring elements may be employed. In someembodiments, the spring elements 1711, 1713 may have a spring constantranging between 10 and 30 N/m, more preferably between 15 and 25 N/m,and even more preferably 23 N/m. In some preferred embodiments, theforce required to compress seven spring elements by 15 mm equals 250 g.In some embodiments, the force required to compress the same sevensprings by the same distance ranges between 180 and 230 g. In someembodiments, there are a total of four spring elements 1711, 1713 per 10cm³. Of course, one will recognize that factors such as the springconstants and/or number of springs may be tailored to the particulartissue type and wound closure desired, and that higher or lower springconstants or numbers of springs may be used.

Standoffs 1707 and 1708 may be provided at the edges or along the outerfaces of the structure 1701, and which may be configured to contact thewound. In some embodiments, the standoffs 1707, 1708 may be extensionsof the beams 1703, 1705, or may be provided separately. In someembodiments, the standoffs 1707, 1708 may be provided with hook oranchor elements configured to anchor tissue placed into contact withthem. Additionally or alternatively, hook or anchor elements attached tothe structure 1701 may be provided separately from or instead of thestandoffs 1707, 1708. Such hook or anchor elements may be useful toenhance fascial tissue closure by ensuring that different tissue layers(e.g., muscle tissue, fat tissue) are closed at approximately the samerate. Preferably, the hook or anchor elements are configured so as to behave a release force (once engaged into tissue) that causes no orminimal pain to the patient while permitting sufficient pulling force tobe applied thereto so as to allow for wound closure. In someembodiments, different anchor elements may be used to engage differenttypes of tissue. For example, the release force to release an anchorelement from subcutaneous fatty tissue may be lower than the forceneeded to release another anchor element from muscle tissue.

Further, the anchor elements, by virtue of their attachment to thesurrounding tissue, may be useful in helping prevent a drape or othermaterials placed over the wound from going into the edges between theskin and the structure 1701. In some embodiments, the anchor elementsmay be broken off, which may aid in sizing the device as described belowso as to fit into a wound. Additionally, all or part of the structure1701 may be covered or embedded within a porous wound filler material.In such configurations, the standoffs 1707, 1708 may be used to provideadditional securement to any such wound filler material.

In use, the stabilizing structure 1701 may be constructed and/ormodified as appropriate to fit the wound. Foam may also be added intothe entire structure 1701, including its interior portions, and if thisis done during manufacturing, the structure 1701 is preferably capableof withstanding a reticulation process. Such a device comprising foamwill have composite tensile structures that are to be considered wheninserting the device into the wound. When inserting the device into thewound as part of a bespoke wound filler, the stabilizing structure 1701is preferably oriented such that the planar support structures 1702 arealigned such that they are perpendicular or substantially perpendicularto the general direction of wound closure, or perpendicular orsubstantially perpendicular to the patient's skin. Optionally, an organprotection layer, which may comprise a polymer sheet or other flexiblematerial, optionally provided with apertures, may be placed into contactwith at least the bottom portion of the wound and the wound filler.FIGS. 7A-E illustrate different views and photographs of embodiments ofa wound closure device comprising a stabilizing structure 1201. Thisembodiment is similar in some respects and in function to the embodimentdescribed above in relation to FIGS. 6A-D, and shares similar elements.The device comprises beams 1203 and 1205 that form a planar supportstructure 1202 separated by spring elements 1211 and 1213. Standoffs1207 and 1208 may also be provided. Here, however, the spring elements1211 and 1213 are thicker and have portions that are bent relative toeach other at acute angles. Additionally, compared to FIGS. 6A-D, thestructure 1201 has a greater volume and greater number of springelements 1211, 1213. As illustrated best in FIG. 7D, the spring elements1211 form a repeating diamond pattern within a first plurality ofparallel planes, with the diamond location being staggered betweenadjacent parallel planes. A corresponding pattern is employed for springelements 1213 with a second plurality of parallel planes. A similarconfiguration may be seen in FIGS. 6A-6D.

EXAMPLE 1

By means of a non-limiting example, an experiment was conducted todetermine the effectiveness of an embodiment of the wound closuredevices described above, with testing being performed on a cadavericmodel. In this particular example experiment and in other examples, thestabilizing structure encompasses the majority of the wound filler,however as described elsewhere, stabilizing structures may encompass themajority of volume of a wound filler or only a small portion. FIGS. 8A-Billustrate the results where a structure with foam, similar to theembodiments of FIGS. 7A-E, was placed into a wound. The perimeter of thestructure was wrapped in a layer of foam.

Wound area measurements before and after application of negativepressure indicated that the wound area decreased by 64%, from 152 mm² to55 mm².

EXAMPLE 2

This non-limiting experiment tested a structure wrapped in foam andprestretched along its width and held in place by bendable plasticstrips, but otherwise similar to the embodiments of FIGS. 7A-E. FIGS.9A-B illustrate the wound size before and after application of negativepressure. Here, the wound area measured 154 mm² before the applicationof negative pressure, and 101 mm² afterwards, for a 34% reduction inwound area.

EXAMPLE 3

FIGS. 10A-B illustrate the non-limiting results of an experiment where astructure similar to the embodiment of FIGS. 7A-E was placed into awound without any foam wrapping. The experiment was performed similarlyto the other examples described in this section or elsewhere in thisspecification, and here, the wound area measured 126 mm² beforeapplication of negative pressure, and 53 mm² afterwards, for a 58%reduction in wound area.

Stabilizing Structures and Wound Closure Devices of FIGS. 11A-19B,22-23B and 35

FIGS. 11A-E illustrate additional embodiments of a wound closure devicecomprising a stabilizing structure 1100. FIG. 11A shows a perspectiveview of an embodiment of a stabilizing structure 1100. Here, thestabilizing structure 1100 is preferably comprised of two or moreinterlocking strips (described below in more detail with relation toFIG. 8B) that extend in directions approximately perpendicular to eachother when in a substantially uncollapsed configuration. The stabilizingstructure is preferably configured to collapse in one direction or alonga first plane while remaining relatively rigid and collapse-resistant ina direction perpendicular to the first direction or plane.

FIG. 11B illustrates side views of a bottom strip 1102 and a top strip1104 that may be used to make a stabilizing structure 1100 such as theembodiment illustrated in FIG. 11A. Each of the top and bottom strips1102, 1104 are preferably configured to movably interlock with eachother, for example via matching notches 1106 and 1108. One or morenotches 1106 may be provided on a top side of bottom strip 1102, andsimilarly, one or more notches 1108 may be provided on a bottom side oftop strip 1104. When assembled together, the one or more top and bottomstrips 1102, 1104 may be positioned so that the notches 1106, 1108 lineup. Preferably, the top and bottom strips 1102, 1104 are positioned atsubstantially perpendicular angles to each other, thereby permitting thenotches 1106, 1108 to slot together so as to create a movablyinterlocking structure. Typically, the number of notches 1106 on thebottom strip 1102 will equal the number of top strips 1108 that willform the stabilizing structure 1100, and vice versa. The notches 1106,1108 are preferably shaped with a width that permits the strips 1102,1104 to move from approximately perpendicular angles to angles far fromperpendicular (i.e., close to parallel) to each other, thus permittingthe stabilizing structure 1100 to articulate and collapse along onedirection or plane.

In a preferred embodiment, the strips 1102, 1104 are constructed from arigid or semi-rigid material, such as a polymer. Examples of suitablepolymers include polyethylene, polypropylene, polyurethane, polyvinylchloride, polystyrene, polyacrylate, polymethyl methacrylate, PEEK,silicone, polyurethane, polycarbonate, composites and laminates, orcombinations thereof. In some embodiments, the material may includecompressed or “felted” reticulated foam. Of course, other materials,such as cardboard or metal may be used. Preferably, the materials may beat least partially porous so as to permit fluid to flow through thematerial. Further, such properties may aid in distributing negativepressure through the device and to the wound, and may aid in removingfluid from the wound dressing. Such materials may include, for example,low density polypropylene, foamed material, or sintered material. Thematerial used does not necessarily need to be strong along the length ofthe strips 1102, 1104, but should preferably be able to withstandpressure applied to a top or bottom edge. Preferably, the material iscapable of withstanding the pressure from atmospheric pressure exertedon a drape when up to 200 mmHg negative pressure is applied to thewound. In some embodiments, the material can withstand a force of 5 psiapplied to a top or bottom edge.

In a preferred embodiment, each strip 1102, 1104 measures 180 mm long by30 mm high. The thickness of the strips 1102, 1104 may range, forexample, between 1.50 to 2.40 mm, although the thickness will beselected at least partly based on the ability of the material towithstand pressure being applied along its edge. The thickness ispreferably balanced between keeping the material thin enough to minimizethe compressed thickness of the stabilizing structure 1000, whilekeeping the material thick enough to avoid causing excessive localizedpressure upon the wound bed. The notches 1106, 1108 may measureapproximately 15mm in height, and may be spaced apart from other notchesby 18mm. Although the notches 1106, 1108 are shown with rounded bottoms,these may also be cut with squared-off or triangular bottoms. In someembodiments, the rounded edges reduce stresses onto the strips 1102,1104 so as to prevent fracture and crack propagation, and may alsoincrease the springiness of the stabilizing structure 1100.

It will be understood that the interlocking strips 1102, 1104 may notnecessarily need to be joined together via notches. Hinges or otherdevices could be used to provide the articulation or movableinterlocking ability illustrated above. In some embodiments, hinges maybe constructed from thinner areas of the same material used to constructthe strips 1102, 1104, and are configured to flex or bend to apredetermined position. The stabilizing structure 1100 could also bemolded as a single piece such that the interlocking strips 1102, 1104form a single unit.

Returning to FIG. 11A, the perspective view illustrates an example of astabilizing structure 1100 configuration with multiple interlocking topand bottom strips 1102, 1104 movably interlocked via multiple notches1106, 1108. The intersections of two top strips 1102 and two bottomstrips 1104 form a quadrilateral-shaped boundary space 1109. When thetop and bottom strips 1102, 1104 are at perpendicular angles to eachother, the space 1109 will be square or rectangular. However, as thestabilizing structure 1100 collapses along a direction or plane, thespace 1109 will become more diamond- or parallelogram-shaped. Thestabilizing structure 1100 will preferably comprise multiple spaces1109, which form cells defined by the walls of the top and bottom stripsand with openings on top and bottom ends.

FIG. 8C illustrates a top view of an embodiment of the stabilizingstructure 1100 where a porous wound filler material 1110 has beenfabricated into the quadrilateral-shaped boundary space 1109. Here, theporous wound filler material 1110 used is preferably soft andconformable so as to be able to adapt to the any change in theconfiguration of the stabilizing structure 1100 if it collapses.Preferably, the porous wound filler material is a foam, such as apolyurethane foam. This porous wound filler material may be fabricatedaround the stabilizing structure 1100 so as to completely encapsulateit. When used, the resulting stabilizing structure 1100 may be cut tosize so as to fit into a wound. Such porous wound filler material 1110may be used to aid in the fluid transmission or wicking of fluid fromwithin a wound, and may also, when in contact with the wound (e.g., whenused in negative pressure wound therapy), aid in the healing of thewound.

FIG. 11D illustrates a perspective photograph of an embodiment of thestabilizing structure 1100 with a porous wound filler material 1110fabricated into the spaces 1109. In some embodiments, additional porouswound filler material may also be used to encapsulate or surround thestructure 1100. For example, a sock or wrap may be fabricated around thestructure 1100, and may for example be constructed from foam or gauze.When inserted into a wound as part of a fabricated wound filler, thestabilizing structure 1100 may be preferably oriented so as to collapsein a direction generally parallel with the orientation of collagen andother fibrous tissue fibers in the body. This orientation is sometimesreferred to as Langer's lines or Kraissl's lines, and closing a wound ina direction coinciding with (and preferably parallel to) these lines mayheal faster and more easily than attempting to close a wound in adirection perpendicular or opposed to these lines. It will beappreciated that the other embodiments of stabilizing structuresdescribed in this specification may also be oriented in the same mannerwith respect to Langer's lines or Kraissl's lines, or other landmarks.

Advantageously for some types of wounds, the stabilizing structure ofFIG. 11A may elongate in a direction perpendicular to the primarydirection of closure, but still within the horizontal plane. Suchelongation can be beneficial to wound healing as the physiology of thewound may dictate that it should lengthen as it closes.

In use, the stabilizing structure 1100 may be placed into a wound suchthat the upward facing portion of the structure 1100 is substantiallyrigid and resists collapse in the vertical direction once negativepressure is applied to the wound (e.g., once covered by a drape asdescribed previously). A porous material such as foam may be fabricatedaround, into, and/or so as to surround or encapsulate the stabilizingstructure 1100. In some embodiments, an organ protection layer asdescribed previously may be placed into contact with at least the bottomportion of the wound or may be fabricated as part of the wound filler.As negative pressure is applied, the structure 1100 will then preferablycollapse in the plane perpendicular to the vertical direction, aiding inwound closure. Due to the relative incompressibility of the verticaldimension of the device, the pressure on the drape transmitted from thegreater atmospheric pressure onto the wound will reduce the pressureapplied to the stabilizing structure 1100 onto the wound margins incomparison to existing prior art devices (such as those illustrated inFIGS. 5A-B). Optionally, in this and other embodiments described in thissection or elsewhere in this specification, negative pressure may beapplied so as to increase transmission of negative pressure to the sidesof the wound rather than the bottom portions thereof. This may beaccomplished, for example, by providing an organ protection layer thatat least partially shields the bottom of the wound from negativepressure. In a preferred embodiment, the sides of the wound would beprovided with negative pressure of at least 100 mmHg, preferably 120mmHg, 140 mmHg, 180 mmHg, or 200 mmHg, while the bottom of the woundwould be provided with at most 120 mmHg, more preferably 80 mmHg, 40mmHg, 20 mmHg, or 10 mmHg.

FIG. 11E illustrates a CT image of an embodiment of a stabilizingstructure 1100 described in FIGS. 11A-D inserted into an abdominalwound. The tissue fascia layers are also visible, with a subcutaneousfat layer 1190 above a layer of muscle tissue 1192. With the applicationof negative pressure (as illustrated), improved fascial reapproximationand wound closure may be observed. In particular, the muscle tissuelayers 1192 on opposite sides of the wound have been moved much closertogether, while remaining attached to the other fascial layers. Inmeasurements, the width of the wound along the view illustrated reducedfrom approximately 82 mm to 28 mm, a reduction of 65%.

FIGS. 12A-C illustrate an embodiment of a wound closure devicecomprising a stabilizing structure 1100 similar to that described abovein relation to FIGS. 11A-E. Here, the stabilizing structure 1100 isconstructed from interlocking strips constructed from felted foam. Thephysical relationship between and the mechanism for the interlocking topand bottom strips 1102 and 1104 are substantially similar to what wasdiscussed previously above, and will not be repeated here. Felted foam,however, is foam (e.g., polyurethane foam) that has been treated withheat and compressed. After this procedure, the foam will be stiffer andless compressible, while still remaining porous. Such a material may beproduced via a 3D fabrication device. Additionally, such a material maybe advantageously used in a stabilizing structure 1100 used for a woundclosure device, as the material may be compressible in a plane definedby the top and bottom strips 1102, 1104, as shown in FIG. 9B. However,the material is substantially rigid in the vertical direction, asillustrated in FIG. 9C, where a weight has been placed over the foamwithout substantial buckling. Here, the foam can support approximately 6kg of weight, and embodiments of the device have been measured tosupport at least 3 psi of applied pressure without collapse. Further,while such material is substantially rigid, the porous nature of thematerial permits negative pressure to be transmitted to the wound andfor wound exudate to be removed.

FIGS. 13A-B are photographs of further embodiments of wound closuredevices. FIG. 13A illustrates an embodiment of a wound closure device1301 that preferentially collapses along one direction. Here, the woundclosure device 1301 comprises a porous wound filler material (e.g.,foam) into which one or more slots 1303 have been fabricated. Theseslots 1303 preferably extend longitudinally through the thickness of thewound closure device 1301. Accordingly, the empty space will permit thewound closure device to preferentially collapse in a direction when aforce is applied in a direction perpendicular to the slots 1303. Becausethe empty space is easier to compress than the remainder of the foam,the width and thickness of the foam will preferably not (or minimally)compress compared to the resulting compression perpendicular to thelength of the wound closure device 1301.

As illustrated in FIG. 13B, the wound closure device 1301 may also beprovided with holes or cells 1305 in other configurations, such asdiamond-shaped holes forming a lattice. This configuration permitscompression along the length and width of the wound closure device dueto the compressible holes 1305, while the comparatively more rigidthickness of the foam resists compression to a greater extent.

In some embodiments, as described above with respect to 3D fabrication,stabilizing structures similar to those illustrated above in FIGS. 11A-Emay be fabricated as a single unit. As with the previously-describedembodiments, the stabilizing structures are configured to form an arrayof one or more cells defined by one or more walls and forming a plane,with each cell having a top and bottom end with an opening extendingthrough the top and bottom ends in a direction perpendicular to theplane. In some embodiments, the stabilizing structures may have cellsthat are square, diamond, oblong, oval, lozenge, and/or parallelepiped,and non-limiting examples of the same are illustrated in FIGS. 14-23.While some embodiments may have cells that are all the same shape, thecells may also be tailored to be larger, smaller, or differently-shapedthan other cells in the structure. The shape and size of the cells maybe tailored to the desired characteristics (e.g., resilience and ease ofcollapse) for optimal wound closure and healing.

Construction of a single unit stabilizing structure may be advantageousin terms of ease of use and cost. For example, single unit stabilizingstructures may be trimmed post fabrication as necessary to fit into awound site, although as described elsewhere in the specification, 3Dfabrication techniques allow a wound filler to be formed to the shape ofa wound during fabrication. The material used is preferablybiocompatible, and even more preferably nonadherent to the wound site.Suitable materials are preferably chosen to be soft while remainingsufficiently strong to resist collapse in a vertical direction, and mayinclude polymers, such as polyethylene, polypropylene, polyurethane,silicone (including siloxanes), ethyl vinyl acetate, and copolymers andblends thereof. The hardness of the material may affect the thickness ofthe resulting stabilizing structure, and may be selected based upon thedesired thickness of the stabilizing structure components (includinghinges and other joints thereof) and the ability of the stabilizingstructure to resist collapse, e.g., due to the atmospheric pressureacting upon a drape placed over the stabilizing structure. Suitabledurometer hardnesses of materials used range from about 30 shore to 120shore (as measured on the Shore durometer type A scale), preferably fromabout 40 shore to 60 shore, and even more preferably about 42 shore.Generally, the material chosen is preferably softer (while stillsatisfactorily meeting other material requirements), as harder materialsmay provide reduced levels of closure as the hardness increases.

FIG. 22 is a photograph of an embodiment of such device 1100 constructedas a single unit. The apertures 1109 are fabricated to be filled with aporous material 1110, which in some embodiments may comprise foam. Here,the fabricated wound filler 1100 is inserted into a wound.

FIGS. 14A-B illustrate an embodiment of a stabilizing structure 1100configured to preferentially collapse in only one horizontal directionwhile remaining substantially rigid or uncollapsed when force is appliedin a vertical direction. Preferably, the stabilizing structure 1100 isconstructed as a single unit as illustrated so as to form one or morecells 1131. Here, two or more longitudinal strips 1120 (which form thewalls of the cells) may have relatively straight configurations, and areconnected together via one or more collapsible cross strips 1122. Itwill be appreciated that in a single unit embodiment, the strips aremerely portions of the same material that may have been formed togetherto form the entire single unit structure. The collapsible cross strips1122 may be angled or indented so as to make them more likely tocollapse in a direction generally parallel to their length. In thisembodiment illustrated in this section or elsewhere in thisspecification, the collapsible cross strip 1122 is more likely tocollapse at the apex of the angled portion and at the junctions to thelongitudinal strips 1120 when a force is applied in a directionapproximately parallel to the general length of the collapsible crossstrip 1122. In some embodiments, the collapsible cross strip isconfigured to fold into a portion (which may be thinner) of thelongitudinal cross strip 1120.

In some configurations, one or both of the longitudinal strips 1120and/or collapsible cross strips 1122 may comprise one or more notchespositioned along a length thereof. These notches promote fluid transferacross the structure, and aid in distributing negative pressure. In someembodiments, notches may be used in conjunction with a porous materialso as to enhance fluid transfer. In relation to the longitudinal strips1120, the collapsible cross strips 1122 may be positioned alternatelyalong the length of the longitudinal strips 1120, as best illustrated inFIG. 14B, to form a configuration somewhat analogous to a “stretcherbond” used in bricklaying. Of course, other configurations are possible.Further, although this embodiment is illustrated as being formed as asingle unit, those of skill in the art will recognize that thisembodiment (and the others described below) may be constructed frommultiple pieces joined or connected together.

FIGS. 23A-B are photographs of an embodiment of a stabilizing structure1100 similar to the one described above in relation to FIGS. 14A-B.Here, the structure 1100 is inserted into a wound 1140 and placed undera drape 1145. A source of negative pressure is connected via a fluidicconnector 1150. FIG. 23B is a closeup view of the stabilizing structure1100 photographed in FIG. 23A, which illustrates how the cells 1131collapse upon the application of negative pressure while under the drape1145. An optional porous wound filler 1148 is also illustrated. As withthe other stabilizing structures and/or wound closure devices describedelsewhere in the specification, the stabilizing structure of FIGS. 23A-Bmay be incorporated as a region or regions of a fabricated wound filler.

FIG. 15 illustrates another embodiment of a stabilizing structure 1100,here comprising two or more longitudinal strips 1120 attached to eachother via one or more angled cross strips 1124 so as to form cells 1131.As with the embodiment illustrated in the preceding figure, thestabilizing structure 1100 is configured to collapse when pushed in adirection perpendicular to the length of the longitudinal strips 1120,while remaining substantially rigid or uncollapsed when force is appliedin a vertical direction. The angled cross strips 1124 are preferablyattached to the longitudinal strips 1120 so as to form anon-perpendicular angle so as to promote collapse of the stabilizingstructure 1100 in the direction perpendicular to the length of thelongitudinal strips 1120. As with FIGS. 11A-B, one or more notches maybe formed on either or both of the longitudinal strips 1120 and/orangled cross strips 1124.

FIG. 16 illustrates a single unit stabilizing structure 1100 comprisingone or more pairs of curved longitudinal strips 1126. Each individuallongitudinal strip 1126 may be formed as a “wavy” strip (when seen froma vertical orientation) that, when joined face-to-face, form a one ormore circular or ovoid cells 1127. As with the other stabilizingstructures illustrated in this section or elsewhere in thisspecification, this structure 1100 is configured to preferably collapsealong a horizontal plane or direction while remaining substantiallyrigid or uncollapsed when force is applied in a vertical direction.Although the structure 1100 is illustrated here as being formed from asingle unit, the structure may be constructed from two or more curvedlongitudinal strips 1126 welded or attached together at the pointsshown. As with several other embodiments described in this section orelsewhere in this specification, one or more notches may be made ontothe walls so as to aid in fluid transfer across and through thestructure 1100.

FIG. 17 illustrates a stabilizing structure 1100 similar to the oneillustrated in FIG. 16. Here, however, zigzag longitudinal strips 1128are joined to form diamond-shaped (rather than circular or ovoid) cells1129. It will be of course appreciated that this embodiment may also befabricated using substantially straight strips in a style similar to theembodiments illustrated in FIGS. 11A-D.

FIG. 18 illustrates a stabilizing structure 1100 comprising verticalsegments 1130 joined together at approximately perpendicular angles soas to form quadrilateral or square cells 1131. Preferably, the verticalsegments 1130 are of a square or rectangular shape, with tapers 1132that join the segments together in a movable and flexible configuration.As with the other embodiments described in this section or elsewhere inthis specification, this stabilizing structure 1100 may be fabricated asa single unit, and is preferably configured to collapse in a horizontalplane or direction while remaining substantially uncollapsed in avertical direction.

FIG. 19A-B illustrates another stabilizing structure 1100 similar to theembodiment illustrated above in FIG. 18. The vertical segments 1130 arepreferably joined together so as to form one or more quadrilateral orsquare cells 1131. Here, however, the vertical segments 1130 do notcomprise a tapered portion 1132. However, one or more notches may bepresent on the underside (wound-facing side) of the structure 1100, andwhich function as described in preceding embodiments. Although thisembodiment may be manufactured from multiple vertical segments 1130, itis preferably molded as a single unit.

FIG. 19B illustrates a CT image of an embodiment of a stabilizingstructure 1100 as described above in relation to FIG. 19A, and which hasbeen inserted into an abdominal wound. Subcutaneous fat layers 1190 arebilateral and present over muscle tissue layer 1192. Upon application ofnegative pressure (as illustrated), improved fascial re-approximationand wound closure may be observed. Here, the width of the wound alongthe view illustrated reduced from approximately 82 mm to 52 mm, areduction of 37%. As with the other stabilizing structures and/or woundclosure devices described elsewhere in the specification, thestabilizing structure of FIGS. 19A-B may be incorporated as a region orregions of a fabricated wound filler.

In some embodiments, the stabilizing structures described in thissection or elsewhere in this specification (such as those described inFIGS. 14A-19B) may be fabricated from a single type of material, such asa plastic. In other embodiments, the stabilizing structures described inthis section or elsewhere in this specification may be fabricated via aprocess whereby the more rigid portions of the structure are fabricatedfirst and the hinges or flexible portions are fabricated second. Infurther embodiments of the stabilizing structure described in thissection or elsewhere in this specification, a soft polymer could befabricated over the entire structure to soften the feel of the device,thereby protecting the surrounding organs and/or other tissues. In otherembodiments, the soft polymer could be fabricated only on the bottomportion of the stabilizing device, while in some embodiments the softerpolymer can be fabricated over the top and/or the sides of the device.In some embodiments, the soft polymer could be fabricated overparticular edges of the stabilizing structure, such as those on thebottom, sides, and/or top. In certain embodiments, the soft polymercould be fabricated over any side or combination of sides of thestabilizing device. The soft polymer may act like a softened rimsurrounding the hard edges of the stabilizing structure.

FIG. 35 illustrates an embodiment of a stabilizing structure 3800similar to the structures described in FIGS. 14-19A. In this embodiment,the longitudinal strips 3802 and cross strips 3804 form rows of flexiblecells 3806 that are configured to collapse in a horizontal plane.Because each of the longitudinal and cross strips are formed from thesame flexible material, applying a lateral force to the structure causesthe cells to collapse generally independently of each other. In otherwords, the collapse of one or more cells in a row does not necessarilycause the collapse of other cells in the same row.

EXAMPLE 4

In this next example of a non-limiting experiment involving structuresfor use in regions of a fabricated wound filler, an embodiment of astabilizing structure such as those described above in relation to FIGS.11A-E was inserted into an abdominal wound. In this experiment, and asillustrated in FIG. 20A, white foam inserts were placed into thequadrilateral openings of the stabilizing structure, and the outer edges(in contact with the wound) were wrapped in black foam. The wound andstabilizing structure were then sealed with a drape and connected to asource of negative pressure as described previously.

Wound area measurements were taken before and after activation of thenegative pressure source. Here, the size of the wound before applicationof negative pressure was measured as 171 mm². Upon the application ofnegative pressure, as illustrated in FIG. 20B, the area of the wound wasgreatly reduced to 55 mm², a reduction of 68%. It is noted that here andin the following examples, as the wound area contracts along its width,the length of the wound increases slightly, indicating that the tissuemargins are returning to their original anatomical position.

EXAMPLE 5

FIGS. 21A-B illustrate the results of a non-limiting experiment similarto those illustrated above, where a stabilizing structure similar to theembodiments of FIGS. 11A-E was inserted into the abdominal cavity. Here,the spaces in the quadrilateral openings of the stabilizing structurewere empty, and a layer of foam was wrapped around the outer edges ofthe structure.

Wound area measurements before and after application of negativepressure indicated that the wound area decreased by 63%, from 155 mm² to58 mm².

Without wishing to be bound by theory, the improved reduction in woundarea in the preceding examples as compared to more commonly utilizedpure foam dressings, is believed to be due to the fact that the wounddevices used therein do not significantly compress in a verticaldirection when negative pressure is applied. This is different fromtraditional foam dressings, where the application of negative pressurecauses downward pressure on the foam due to the air pressure pressingonto the drape, [thus causing the foam to collapse towards the woundbed, creating a concave shape to the drape. The atmosphere actspredominantly in a perpendicular direction to the surface of the drape.Thus, on the periphery of the concave shape, closest to the wound edgeor where the drape approaches an angle perpendicular to the plane of thewound, the atmosphere now creates a force in a direction that pushes thewound apart.] Similarly, pressure is transmitted along the foam dressinginto a horizontal force that pushes the wound margins outward.Traditional negative pressure wound treatment typically uses foam (orother porous materials) placed into a wound underneath a drape, to whichnegative pressure is applied to the wound. In such situations, theapplication of negative pressure may cause downward pressure on the foamdue to the air pressure pressing onto the drape, which is thentransmitted along the foam dressing into a horizontal force that pushesthe wound margins outward. Without wishing to be bound by theory, it isbelieved that some of the embodiments of stabilizing structures, woundclosure devices, and wound treatment devices, methods, and systemsdescribed in this specification are able to cause a greater reduction inwound area as compared to traditional negative pressure treatment. Oneof these factors is believed to be because embodiments of thestabilizing structures and wound closure devices described in thissection or elsewhere in this specification do not significantly compressin a vertical direction when negative pressure is applied. With the useof certain embodiments described in this section or elsewhere in thisspecification, foam and other dressing components are not pushed outwarddue to negative pressure, and thus the wound margins may be approximatedmore easily so as to achieve faster wound closure and better woundhealing.

Stabilizing Structures and Wound Closure Devices of FIGS. 24A-30B

FIG. 24A is a photograph of an embodiment of a wound closure devicecomprising a stabilizing structure 2100 that may be placed or insertedinto a wound. Here, the device comprises a plurality of cells 2102provided side-by-side in a generally planar configuration. Preferably,the stabilizing structure 2100 is configured to collapse in a directionalong a plane 2101 defined by the width of the device, withoutsignificantly collapsing in a direction perpendicular to the plane 2101.That is, when viewed in the figure, the stabilizing structure 2100 willcollapse in the horizontal direction, but will not compress in thevertical direction. In some embodiments, the stabilizing structurecollapses in conjunction with the movement of tissue. Here, the cells2102 are preferably open at both ends in a direction perpendicular tothe plane 2101.

Each of the cells 2102 is preferably formed with four walls 2104, eachwall 2104 being joined to the next by a flexible joint 2106. The joints2106 are preferably designed so as to be more flexible than the walls2104, and promote collapse of the stabilizing structure 2100 in thedirection of the plane. Of course, it will be understood that otherconfigurations are possible, and in some embodiments each cell 2102 maybe defined by less than or greater than four walls 2104, for examplefive walls or six walls, thus forming pentagonal or hexagonal cells. Thecells 2102 may not necessarily be symmetric, and can form rectangular,diamond, rhomboidal, trapezoidal, parallelepiped, oblong, oval, lozengeand other such shapes in addition to the square-walled embodimentillustrated in this section or elsewhere in this specification.

One or more of the walls 2104 defining the one or more cells 2102 mayfurther comprise an insert 2115 fabricated and disposed therein, anddescribed in greater detail below in FIGS. 25A-F. Preferably, the insert2115 will be fabricated from a material more rigid than the materialused to construct the remainder of the wall 2104. Some suitablematerials may include metals such as titanium, stainless steel, andlargely inert alloys (such as monel and hastelloy), and/or polymers suchas polyurethane, silicone, rubber, isoprene, polyethylene,polypropylene, nylon, polyacrylate, polycarbonate, and PEEK. Someembodiments may also comprise composite materials, includingresin-reinforced fiber composites where the resin may be, for example,various types of epoxies. Suitable fibers may include glass, carbon,carbon nanotubes, graphene, and aramids (e.g., Kevlar). Preferably, thematerial chosen for the insert 2115 is not only sufficiently rigid, butalso able to adhere to the material used in the wall 2104. For example,the insert material is preferably able to adhere to softer polymers suchas silicones or polyurethanes used in the wall 2104. The more rigidmaterials used in the insert 2115 may provide for additional collapseresistance in the direction perpendicular to the plane for thestabilizing structure 2100.

In some embodiments, one or more notches 2109 may be provided betweenmultiple walls 2104, and which may further aid in permitting theflexible joints 2106 to move. Without wishing to be bound by theory, thenotches 2109 may also aid in distributing negative pressure andtransmitting fluid throughout the stabilizing structure 2100 whennegative pressure is applied, for example in a clinical care setting.Some embodiments may also comprises holes in the walls 2104 or joints2106, or be constructed from porous materials.

Preferably, a cavity 2108 is provided within each wall 2104 for theinsert 2110 to be fabricated within the cavity. In some embodiments, thewalls 2104 may be fabricated around each insert 2115. An insert 2115 mayalso be inserted into the cavity 2108 after the wall 2104 is fabricated.For example, the insert and wall could be fabricated separately via 3Dfabrication techniques, and then the insert later inserted into thecavity via suitable means. While the embodiment illustrated here and inthe subsequent images shows a single insert 2115 in each wall 2104, someembodiments may be provided with one or more inserts 2115 disposedtherein.

FIG. 24B illustrates an embodiment of a stabilizing structure 2100 withmany similar features to FIG. 24A. Here, an insert 2111 comprisesstructural differences compared to the insert 2110, and is discussed inmore detail below in relation to FIG. 22E. When inserted or fabricatedwithin the cavity 2108, one or more of the walls 2104 may comprise ahole 2105 communicating through at least one aperture in the insert2111. In addition to any notches 2109, the one or more holes 2105 maypermit additional displacement of wound exudate and distribution ofnegative pressure within the stabilizing structure 2100.

FIG. 24C illustrates an embodiment of a stabilizing structure 2100 withsimilar features as the other embodiments described previously. In thisembodiment, the stabilizing structure 2100 comprises an insert 2112described in greater detail below in FIG. 25F.

Similarly, FIG. 24D illustrates an embodiment of a stabilizing structure2100 comprising an insert 2113 described in greater detail below in FIG.25D. FIG. 24E illustrates an embodiment of a stabilizing structure 2100comprising an insert 2114 described in greater detail in relation toFIG. 25A.

In the preceding embodiments of stabilizing structures 2100 comprisingvarious inserts 2110, 2111, 2112, 2113, 2114, and 2115, it will ofcourse be understood that embodiments of the stabilizing structure 2100do not need to contain only one type of insert. Likewise, each cell 2102or wall 2104 may comprise one or more different types of inserts, or noinserts at all. Varying the different inserts and other properties ofthe cells 2102 and walls 2104 may thus permit the stabilizing structure2100 to be tailored to the appropriate wound type so as to effectoptimal wound closure and/or treatment.

FIGS. 25A-F illustrate examples of different inserts that may be used aspart of a stabilizing structure 2100. Preferably, these inserts may beplaced, molded into, or formed as part of a wall 2104 in a stabilizingstructure 2100 (e.g., of the types illustrated above in FIG. 24A-E).Various modifications may be made, as described below, that may improveor alter characteristics of the inserts.

Turning now to FIG. 25A, the embodiment of the insert 2114 illustratedhere is approximately rectangular in shape, and is adapted to beinserted or formed into one or more of the walls 2104 of an embodimentof the stabilizing structure 2100. In some embodiments, one or more ofthe inserts 2114 may have a height greater than the width, and the wall2104 may have a height of at least about mm, at least about 5 mm, atleast about 10 mm, at least about 15 mm, at least about 20 mm, at leastabout 25 mm, at least about 30 mm, at least about 35 mm, at least about40 mm, at least about 50 mm, at least about 75 mm, at least about 100mm, at least about 150 mm, at least about 200 mm, at least about 250 mm,at least about 300 mm, at least about 350 mm, at least about 400 mm, ormore than 400 mm, particularly in extremely obese patients. ,Preferably, in average patients, the heights may range from about 10 mmto 40 mm. These measurements may apply to any stabilizing structuredescribed in this section or elsewhere in this specification.

In some embodiments of any stabilizing structure described in thissection or elsewhere in this specification, the width may be betweenabout 1 mm to 30 mm, 2 mm to 25 mm, 4 mm to 20 mm, 6 mm to 18 mm, 8 mmto 16 mm, or 10 mm to 14 mm, preferably about 10.8 mm. Thesemeasurements may apply to any stabilizing structure described in thissection or elsewhere in this specification.

The insert 2114 is preferably thin but with enough structural strengthto resist collapse, and in some embodiments of any stabilizing structuredescribed in this section or elsewhere in this specification, thethickness may be at least about 0.01 mm to 10 mm, 0.2 mm to 8 mm, 0.4 mmto 6 mm, 0.5 mm to 4 mm, 0.75 mm to 3 mm, or 1-2 mm. These measurementsmay apply to any stabilizing structure and/or wound closure devicedescribed in this section or elsewhere in this specification.

In some embodiments of any stabilizing structure described in thissection or elsewhere in this specification, multiple discretestabilizing structures may be stacked on top of one another to form thewound closure device, to extend the height of the device to any of thedimensions described in this section or elsewhere in this specification(including the dimensions provided for the inserts above). The stackingof multiple stabilizing structures may allow the clinician to havefurther flexibility in their treatment strategies when fabricating awound filler via 3D fabrication techniques.

FIG. 25B illustrates an embodiment of the insert 2110 with a generallyrectangular configuration, but provided with two notches 2201 cutdiagonally across a top end of the insert 2100. The notches 2201 mayfacilitate clearance of the insert 2100 from any notches 2109 that maybe provided in the walls 2104. Further, the notches 2201 may also aid inthe insertion of the insert 2100 into the cavity 2108 of the wall 2104.The notches 2201 may also be helpful in conjunction with the notches2109 in further defining a channel or other opening for fluid to betransmitted or transferred between and through each cell 2102. Thenotches 2201 may also aid in ensuring that the entire stabilizingstructure is able to more easily collapse.

FIG. 25C illustrates an embodiment of an insert 2115 provided with twonotches 2201 as well as a horizontal lip 2203. The horizontal lip 2203may aid in inserting the insert 2115 into the cavity 2108 of the wall2104, or may aid in fixing the wall 2104 around the insert 2115 when thewall is fabricated around it. The horizontal lip 2203 may be beneficialin effectively reducing the bulk of the insert at one end of the wall2104, and in conjunction with a softer material used in the wall 2104,may thereby increase comfort due to the correspondingly greater amountof wall material. In some embodiments, the horizontal lip 2203 and/ornotches 2201 may be present on both ends of the insert 2115 or otherinserts described in this section or elsewhere in this specification. Insome embodiments, the horizontal lip 2203 is approximately half thethickness of the overall insert 2115. For example, the insert 2115 maybe between 0.5 mm and 4 mm in thickness, preferably 2 mm. If the insert2115 measures 2 mm in thickness, the thickness of horizontal lip 2203may be 1 mm.

FIG. 25D illustrates an embodiment of the insert 2113, and which issimilar to the embodiment used in the stabilizing structure 2100illustrated in FIG. 24D. This insert 2113 may comprise one or moreapertures 2205, which in some embodiments may communicate with one ormore holes 2105 that may be formed through one or more walls 2104. Insome embodiments, the apertures 2205 are arranged in a 2×3 patternillustrated here, although other arrangements are possible. Notches 2201may also be present.

FIG. 25E illustrates an embodiment of the insert 2111, which is similarto the embodiment used in the stabilizing structure 2100 illustrated inFIG. 24B. The insert 2111 preferably comprises two notches 2201. Ahorizontal lip 2203 may also be provided. Preferably, one or moreapertures 2205 may be formed therein. In some embodiments, one or moreof the apertures 2205 may extend to the edge of the insert 2111 asillustrated. In some embodiments, the apertures 2205 may be configuredto have four apertures arranged around a central aperture, althoughother configurations are of course possible. In some embodiments, thereduced amount of insert material at the locations of the apertures maybe advantageous to provide a greater amount of softer wall material at ahinge point, where this may consequently increase flexibility. In apreferred embodiment, the insert 2111 has a height of 25 mm and a widthof 10.8 mm, with a thickness of 2 mm. The first set of apertures may becentered approximately 5 mm from the bottom edge of the insert 2111, thecentral aperture may then be centered approximately 11 mm from thebottom, and the top set of apertures may be centered 17mm from thebottom.

FIG. 25F illustrates an embodiment of the insert 2112, which shares somesimilarities to the embodiment used in the stabilizing structure 2100illustrated above in FIG. 24C. The insert 2112 preferably may compriseone or more channels 2207 formed therein. Preferably, the one or morechannels 2207 are disposed in a horizontal configuration across thewidth of the insert 2112. While the insert 2112 is preferablyconfigured, like several other embodiments described in this section orelsewhere in this specification, to remain substantially uncompressed inthe vertical direction, the inclusion of one or more horizontal channels2207 may aid in providing additional rigidity in the direction of theplane defined by the cells 2102. In such a case, the rigidity of the oneor more walls 2104 may be enhanced, and may thus control the compressionof the stabilizing structure 2100 such that any collapse or bendingoccurs substantially only at the one or more joints 2106.

FIGS. 26A-F illustrate an embodiment of a stabilizing structure 3001configured to be inserted into a wound, acting alone as a wound filleror as a region or regions within a larger fabricated wound filler. Thestabilizing structure 3001 preferably comprises at least one top strip3002 extending in a first direction (e.g., along an x axis) and at leastone bottom strip 3004 extending in a second direction (e.g., along a yaxis perpendicular to the x axis), these being preferably arranged intoan array comprising multiple strips 3002, 3004. The strips 3002, 3004are preferably connected together in a movably interlockingconfiguration, which preferably comprises an interlock mechanism 3006.The strips 3002, 3004 are preferably arranged in an un-collapsedconfiguration wherein the strips 3002 and 3004 are disposed at anglesapproximately perpendicular to each other. This arrangement forms afirst plane that the stabilizing structure 3001 preferably adopts.Preferably, the stabilizing structure 3001 is more rigid in thedirection perpendicular to the plane (i.e., in the vertical direction oralong a z axis), and thereby substantially resists compression ordeformation in that direction.

To aid in the closure of a wound, the stabilizing structure 3001 ispreferably movable from the substantially un-collapsed configuration toa collapsed configuration, as illustrated in FIG. 26F. This may bebeneficial for wound closure and healing, as described previously. Inuse, negative pressure may apply a closing force across the margins ofthe wound containing a wound filler comprising the stabilizing structure3001. As the structure 3001 is preferably configured to be substantiallyrigid in the vertical direction (i.e., perpendicular to the planedefined by the structure 3001), pressure resulting from atmosphericpressure exerted onto the structure 3001 via the drape is focusedsubstantially downward rather than outward, such that the wound marginsare no longer pushed outward as in conventional negative pressuredressings.

Preferably, the structure 3001 adopts a smaller area in the first planeas a result of moving to the compressed configuration. As such, thestructure 3001 aids in wound closure by aiding re-approximation of thewound margins. In some embodiments, the stabilizing structures describedin this section or elsewhere in this specification are able to reducetheir captured volume when in a collapsed configuration (i.e., thevolume change between an uncompressed and compressed stabilizingstructure) by at least 10%, preferably at least 15%, and even morepreferably at least 25%.

FIGS. 26C-E illustrate close-ups of the interlock mechanism 3006. It isto be noted that although reference may be made to various parts of theinterlock mechanism 3006 being present on either the top strip 3002 orbottom strip 3004, this description should not be considered as limitingin terms of orientation, and the same interlock mechanism 3006 may beconstructed with the top or bottom strips 3002, 3004 reversed.

In a preferred embodiment, the interlock mechanism 3006 preferablycomprises two clasps 3010 extending downward from the top strip 3002.Preferably, the clasps 3010 are parallel to each other so as to be onopposite sides of a projection 3012 extending upward from the bottomstrip 3004. The clasps 3010 preferably comprise a lip or hook 3011 thatmay secure themselves under an end 3013 located at the distal end of theprojection 3012. In a preferred configuration, the enlarged end 3013 isarranged such that all or a portion of the lip 3011 engages with theenlarged end 3013. The combination of the lip 3011 and enlarged end 3012may aid in preventing the top strip 3002 from disengaging in a verticaldirection away from the bottom strip 3004. In some embodiments, theprojection 3012 may abut on the bottom edge of the top strip 3002. Insome embodiments, however, and as illustrated here, a stabilizing post3014 may be present to locate the distal side of the projection 3012 andenlarged end 3013.

FIGS. 27A-D illustrate an embodiment of a stabilizing structure 3201assembled in a similar manner to the embodiment illustrated above inFIGS. 26A-F. Here, the interlock mechanism 3006 comprises four clasps3010 surrounding the projection 3012 and the enlarged end 3013 of theprojection 3012. Preferably, the clasps 3010 are arranged in a mutuallyorthogonal configuration, although different orientations arecontemplated as well. It will be understood that any number of clasps3010 may be used to secure the projection 3012, for example three orfive clasps 3010.

It will be noted that due to the addition of additional clasps 3010 incomparison to the embodiment illustrated in FIGS. 26A-F, the embodimentillustrated here will have a compressed configuration that is slightlylarger, as illustrated in FIG. 27D. This may be useful in somesituations; for example, some wounds may require a more gradual closureof the wound margins, and the embodiment described here may be welladapted for this purpose. For example, in clinical situations involvingcompartment syndrome, especially in the abdomen, application of fullwound closure may not be appropriate or desirable, as wound closure maycause complications such as excessive pressure on organs and underlyingtissue structures and/or reduction of blood flow to distal anatomicalstructures. Additionally, in some cases a too rapid or complete woundclosure may be too painful for a patient. Accordingly, limiting theamount of closure may therefore be beneficial in such types of wounds.Limiting the amount of closure may also be beneficial in cases ofcompartment syndrome in the lower limbs.

FIGS. 28A-E illustrate an embodiment of a stabilizing structure 3301comprising an interlock mechanism 3006 arranged in a tubularconformation. In this embodiment, a cup-shaped member 3020 is preferablyconfigured to receive the enlarged end 3013 of the projection 3012. Theprojection 3012 may extend vertically from the top strip 3002. Thecup-shaped member 3020 is preferably cylindrical or tubular in shape,and may extend vertically from the bottom strip 3004, although it willbe understood that the cup-shaped member 3020 and projection 3012 may belocated on opposite strips.

Preferably, one or more slits 3021 are formed into the cup-shaped member3020 so as to permit some “give” to permit the projection 3012 to bereceived into the cup-shaped member. A lip or hook 3022 may also aid insecuring the enlarged end 3013 of the projection 3012. A stabilizingpost 3014 may also be present to prevent the projection 3012 fromextending too deeply into the cup-shaped member 3020.

FIG. 28E illustrates a compressed view of an embodiment of thestabilizing structure 3301. Compared to FIG. 26F, this embodiment has aslightly larger compressed configuration.

FIG. 29 schematically illustrates an embodiment of a stabilizingstructure 3400 configured to be inserted into a wound. Here, thestabilizing structure 3400 is shown inserted into a wound 3405.Preferably, the stabilizing structure 3400 preferably comprises at leastone, and more preferably at least two, long strips 3402 whoselongitudinal length may be oriented along a longitudinal axis of thewound 3405, or along a direction along which closure is sought. Each ofthe one or more long strips 3402 are preferably substantially rigid andextend substantially along the entire length of the wound 3405. In apreferred embodiment, the long strip 3402 is continuous and does nothave any breaks or hinges along its length. This is in contrast tocertain other embodiments described above.

One or more struts 3404 are preferably attached at one or more points tothe long strip 3402. Preferably, these struts 3404 are movably attached,for example via a hinge-like attachment or flexible joint, such thatthese may collapse in a direction perpendicular to a longitudinal lengthdefined by the length of the one or more long strips 3402. In someembodiments, the struts 3404 may be angled at a non-perpendicular anglewith respect to the long strip 3402 so as to collapse more readily. Inembodiments comprising two or more long strips 3402, the struts 3404 maybe hinged between two parallel long strips 3402.

It will be recognized that while these struts 3404 may be configured tocollapse along a direction perpendicular to the longitudinal length ofthe one or more long strips 3402, the struts 3404 are preferably rigidin a vertical direction (i.e., in the direction extending upward from aplane defined by the wound 3405). As such, a combination of the struts3404 and the long strips 3402 may thus form a stabilizing structure 3400that is substantially rigid in a vertical direction while beingcollapsible in a horizontal direction perpendicular to the longitudinalaxis of the long strips 3402 (i.e., in the plane of the wound 3405).

FIG. 30A illustrates a top view of an embodiment of stabilizingstructure 3400 cut into an oval shape and inserted into a wound 3405.Preferably, the stabilizing structure 3400 comprises a plurality ofelongate strips 3402 whose longitudinal length may be oriented along alongitudinal axis of the wound 3405, or along a direction along whichclosure is sought. Each of the plurality of elongate strips 3402 ispreferably substantially rigid and extends substantially along theentire length of the wound 3405. A plurality of intervening members arepositioned between adjacent elongate strips 3402. These interveningmembers may be struts 3404 as described with respect to FIG. 29,preferably attached at one or more points to the elongate strips 3402.The intervening members may also be portions of elongate strips such asdescribed with respect to FIGS. 26A-28E above, extending perpendicularor at an angle to elongate strips 3402. The stabilizing structure ofFIG. 30A may also comprise the embodiments described with respect toFIGS. 24A-25F.

FIG. 30B illustrates a top view of an embodiment of an oval shapedstabilizing structure 3400 inserted into a wound 3405. This embodimentmay have the same configuration as described above with respect to FIG.30A. Additionally, foam 3406 can be fabricated between and around thestabilizing structure.

Stabilizing Structures and Wound Closure Devices of FIGS. 31A-34 and36-38

FIG. 31A illustrates an embodiment of a method for the closure of awound using any of the stabilizing structures described in this sectionor elsewhere in this specification before or as hereafter described,through the application of tension along an axis of wound 3405. Asdescribed previously, such stabilizing structures may be incorporated asvarious regions within a fabricated wound filler. In this example, whenthe wound is viewed from above, tension is applied along thelongitundinal axis of the wound, generally represented by arrows 3407.Tension along the longitundinal axis prevents contraction of the woundalong the longitudinal axis, however the tension along the longitudinalaxis can cause the lateral edges of the wound to be drawn together,promoting wound closure. In some embodiments, additional inward tensioncan be applied to the lateral edges of the wound, thereby providingadditional wound closing force.

FIG. 31B illustrates an embodiment of a method for the closure of awound through the use of a stabilizing structure 3400 that collapses andlengthens when a wound is treated under negative pressure. Asillustrated, the stabilizing structure 3400 may be cut to an appropriatesize to approximate the shape of the wound (e.g., in an oval shape), andthe stabilizing structure is placed in the wound 3405. In someembodiments as described above, the stabilizing structure may have aplurality of diamond-shaped cells, and the cells are arranged in thewound in an orientation that causes the cells to be flattened as thelateral edges of the wound come closer together, while becoming longeralong the longitudinal axis of the wound. It will be recognized thatwhile this structure is configured to collapse under negative pressurehorizontally within the wound in a direction perpendicular to thelongitudinal axis of the wound, the structure is substantially rigid inthe vertical direction. Line 3408 represents the length of the structureprior to lengthening under negative pressure, while line 3410 representsthe final length of the structure after collapsing and lengthening undernegative pressure. Lines 3412 and 3414 represent the lengths ofparticular sections within the stabilizing structure. In certainembodiments, when a wound is treated with application of negativepressure, the structure will collapse inward on one axis, therebylengthening the structure by some additional amount in another axis thatcan be the sum of the lengths of lines 3412 and 3414. In someembodiments, the structure can lengthen by amounts other than the sum oflines 3410 and 3412.

In some embodiments, the collapse can occur slowly, thereby applyingincreasing longitudinal tension over a long period of time. In certainembodiments, the collapse and lengthening of the structure can occurimmediately upon application of negative pressure. In furtherembodiments, the collapse can occur at any rate.

FIGS. 32A-C illustrate another embodiment of a stabilizing structure3500. The stabilizing structure 3500 comprises a plurality of elongatestrips 3502 arranged in parallel, and whose longitudinal length can bealigned with the longitudinal axis of a wound when placed in a wound.The stabilizing structure further comprises a plurality of interveningmembers 3504 connected to the elongate strips 3502 by a plurality ofjoints 3506. As illustrated, the plurality of intervening members 3504between adjacent elongate strips 3502 define a row of cells 3508 betweeneach pair of adjacent elongate strips.

In some embodiments, the elongate strips 3502 may be rigid, semi-rigid,and/or flexible. In some embodiments, the elongate strips 3502 arecompressible. As illustrated in FIGS. 32A-32C, one embodiment comprisesa plurality of strips that are rigid in a vertical dimension but alsoare flexible and capable of bending along their length.

In some embodiments, the intervening members 3504 may be rigid,semi-rigid, and/or flexible. In some embodiments, the interveningmembers 3504 are compressible. As illustrated in FIG. 32A-32C, oneembodiment comprises intervening members in the form of panels equallyspaced apart between adjacent strips, to define a plurality ofsimilar-shaped (e.g., diamond-shaped) cells. In other embodiments, theintervening members need not be equally spaced. The intervening membersmay be attached to the strips by joints 3506 in the form of a hinge(e.g., a living hinge or a more flexible piece of material between thestrips and the intervening members).

In some embodiments, the plurality of intervening members 3504 areconfigured to pivot relative to the elongate strips 3502 and to collapseso as to allow the elongate strips to collapse relative to one anotherand come closer together. In some embodiments, the joints 3506 areconfigured to pivot and collapse in only one direction. In certainembodiments, the joints 3506 are configured to pivot and collapse inboth directions, comprising a full 180 degrees of rotation relative tothe elongate strips 3502. In certain embodiments, when the joints pivot,they pivot completely so as to rest the intervening members 3504 againstthe elongate strips 3502. In some embodiments, the joints do not pivotcompletely and the intervening members do not come to rest against theelongate strips 3502.

Preferentially, in certain embodiments, by controlling the direction inwhich the pivoting occurs, the collapsed length of the stabilizingstructure 3500 can be controlled. In particular embodiments, because ofthe rigidity of the elongate strips, the cells 3508 in a row betweenadjacent elongate strips are configured to collapse together as theadjacent elongate strips 3502 collapse relative to one another. In someembodiments, one or more rows of cells 3508 between adjacent strips 3502are configured to collapse in a first direction, and one or more rows ofcells between adjacent strips 3502 are configured to collapse in asecond direction opposite the first direction. As illustrated in FIGS.32A-32C, the orientation of cells in adjacent rows alternates so thatcells of a first row collapse in a first direction, and cells of a nextrow collapse in an opposite second direction. Joints 3506 may beconfigured so that joints 3506 in adjacent rows collapse in differentdirections.

By configuring the joints 3506 and/or cells of the stabilizing structureto pivot and collapse in preferred directions, the length of thecollapsed structure can be modified. The embodiment shown in FIGS.32A-32C will have a shorter collapsed length than a structure where allthe rows of cells 3508 are configured to collapse in the same direction.Thus, the collapsed length of the structure can be controlled dependingon the orientation of the cells and the direction in which theintervening members collapse between adjacent rows. In some embodimentsas described above with respect to FIGS. 31A-31B, the stabilizingstructure preferably lengthens after collapse under negative pressure.In other embodiments, it may be preferred that the stabilizing structurenot lengthen after collapse under negative pressure.

In FIGS. 32A-32C, the intervening members 3504 in adjacent rows aregenerally aligned so that the intervening members connect to theelongate strips at approximately the same location on opposite sides ofthe strip and share the same joint 3506 location. In other embodiments,the intervening members 3504 between a first elongate strip 3502 and asecond elongate strip 3502 are offset relative to intervening members3504 between the second 3502 and a third adjacent strip 3502. In theseembodiments, the intervening members 3504 are staggered such that theydo not share the same joint 3506 location.

As shown in FIGS. 32A-32C, the enclosed cell 3508 formed by twointervening members and two sections of the elongate strips is aquadrilateral. In some preferred embodiments, the enclosed shape can bea square, rectangle, diamond, oblong, oval, and/or parallelepiped. Insome embodiments, the enclosed shape is a rhomboid. In certainembodiments the enclosed shape is a trapezoid.

In certain preferred embodiments, the joint 3506 may be configured tolimit the range of motion of the intervening member 3504, and may beused to prevent the intervening members 3504 from becoming fullyperpendicular to the adjacent strips. Thus, the joint may be configuredto pre-set the intervening members 3504 in a partially collapsedposition. For example, a lip or other portion of material at the jointmay be used to limit the angular motion of the intervening members. Thelip or other portion of material may also prevent the joint fromcollapsing completely flat. In some embodiments, the joint may beconfigured to prevent the intervening members from rotating in 180degrees along the plane formed by the strips.

In some embodiments, when the stabilizing structure 3500 is placed in awound as part of a fabricated wound filler, the elongate strips 3502 arepositioned generally parallel to the lateral edges of the wound.Preferably, the stabilizing structure is configured in the wound suchthat the elongate strips are positioned parallel to the longitudinalaxis of the wound, as described with respect to FIGS. 31A-31B above. Thestrips may also bend along their length and bow outwardly to fit withinthe wound. The stabilizing structure may be cut to an appropriate sizeto fit the structure in the wound. In other embodiments, the elongatestrips 3502 are positioned perpendicular to the edge of the wound, ormay not be oriented along any edge of the wound.

In the embodiments of FIGS. 32A-32C, as well as in other embodiments ofstabilizing structures described in this section or elsewhere in thisspecification, the strips can be constructed from a material selectedfrom the group consisting of silicone, polyurethane rigid plastics,semi-rigid plastics, flexible plastic materials, composite materials,biocompatible materials and foam. In some embodiments, the interveningmembers can be constructed from a material selected from the groupconsisting of silicone, polyurethane, rigid plastics, semi-rigidplastics, flexible plastic materials, composite materials, biocompatiblematerials and foam. In some embodiments, the stabilizing structure issurrounded by absorbent materials. In certain embodiments thestabilizing structure is surrounded by non-absorbent materials. In someembodiments the material surrounding the stabilizing structure is foam.In particular embodiments, the spaces between the intervening members3504 and the elongate strips 3502 are filled with foam.

FIGS. 33A-G illustrate an embodiment of a stabilizing structure 3600that is similar to the ones described above in relation to FIGS. 32A-Cand FIG. 31B. As illustrated in FIG. 33A, in some embodiments, thestabilizing structure 3600 comprises a plurality of elongate strips 3602connected by a plurality of intervening members 3604 at a plurality ofjoints 3606. As illustrated in FIGS. 33A-G, the plurality of interveningmembers comprise a plurality of bars 3604 connecting adjacent elongatestrips and connected to the elongate strips at upper and lower jointlocations. The plurality of joints in one embodiment comprise aplurality of pins 3606 connected to the bars and received in upper andlower vertical openings in the strips 3602. Other types of joints arealso contemplated, including ball joints. The bars are preferablyequally spaced within a row between adjacent elongate strips, and may beoffset or staggered in an adjacent row, such that in an adjacent row,the bars connect to the elongate strip at a location between the bars ofthe first row. In other embodiments, the intervening member can comprisea wire or other elongate structure configured to extend between adjacentelongate strips.

Preferably, as illustrated in the top view of FIG. 33B and the frontview of FIG. 33C, in certain embodiments the pins cause the bars toprotrude above the vertical top and the vertical bottom of the elongatestrips 3602. In other embodiments, the bars 3604 may be connected to theelongate strips so that they are located flush with the vertical top andvertical bottom of the elongate strips 3602. In further otherembodiments, the bars 3604 may be connected so that they are locatedbelow the vertical top of the elongate strips 3602 and above thevertical bottom of the elongate strip.

As illustrated in FIGS. 33A and 33C, the joints 3606 can preferablycomprise a plurality of stops 3608 configured to limit the rotation ofthe bars relative to the strips. The stops may protrude vertically fromthe strips to limit the movement of the bars. For example, these stopsmay be used to prevent the bars from becoming fully perpendicular withrespect to the adjacent strips, and may be used to provide apreferential direction of collapse to adjacent rows. As shown in FIG.33A, a first row may have bars angled in a first direction, and a secondrow may have bars angled in a second direction. In some embodiments,there are two stops per bar on a given strip, to restrict motion in twodirections. In other embodiments, there is one stop or three or morestops per bar on a given strip.

FIGS. 33E-G illustrate the stabilizing structure 3600 in a collapsedconfiguration. Similar to the structures of FIGS. 32A-C and FIG. 31B,the structure 3600 may be positioned in a wound in an orientationconfigured to collapse in a direction perpendicular to the longitudinalaxis of the wound. As described above, the stabilizing structure may besurrounded by or filled with absorbent material such as foam. In oneembodiment, because the vertical space between the upper and lower barsof the structure 3600 are open (as best shown in FIG. 33C), elongateblocks of foam or other compressible material may be placed in betweenadjacent strips to provide a desired compressibility as the structurecollapses.

FIG. 34 illustrates an embodiment of a stabilizing structure 3700 thatis similar to the structures described above in relation to FIG. 31B,FIGS. 32A-C and FIGS. 33A-G. In certain embodiments, the stabilizingstructure 3700 can collapse in any manner described above. The elongatestrip 3702 as illustrated is formed in two halves, and can be separatedalong line 3708. The intervening members 3704 can be in the form ofpanels as described above. The joints 3706 on the upper half of anelongate strip may comprise pins located on opposite sides of the stripextending downward from the top of the upper half of the strip. Thejoints 3706 on the lower half of an elongate strip may comprise pinslocated on opposite sides of the strip extending upward from the bottomof the lower half of the strip. These pins may engage vertical openingslocated at the four corners of the intervening member 3704. As the upperand lower halves are brought together, the pins may engage the openingsin the panels. The upper and lower halves may be secured by any numberof mechanisms, such as with adhesive and mechanical connections.

In the FIG. 34 embodiment, with the ability to separate the two halvesof 3702 along line 3708, intervening members 3704 may be easily removedor replaced. In some embodiments, only some of the intervening members3704 are removed. In certain embodiments, alternating interveningmembers 3704 are removed. In certain preferred embodiments, interveningmembers are removed in a preferential manner so as to allow thestabilizing structure 3700 to collapse in a controlled manner mostappropriate for a particular wound. For example, the joints 3706 mayhave variable levels of resistance to rotation, thus allowing forcontrol over the collapse of the structure by adding or removing theintervening members 3704. Additionally, stops such as those described inrelation to FIG. 33A, could be incorporated into the structure or anyother structure described in this section or elsewhere in thisspecification to further control collapse. In some embodiments, theintervening members are replaced or removed to maximize the collapsedlength of the structure 3700. In certain embodiments, interveningmembers are replaced or removed to minimize the collapsed length ofstructure 3700. In some embodiments, intervening members are replaced orremoved to attain a desired length for the collapsed structure.

FIG. 36 illustrates another embodiment of elongate strips 3900 that maybe used to form a stabilizing structure, similar to that described inFIGS. 11A-D. The first strip 3902 illustrated in the upper portion ofFIG. 36 may be an elongate strip having a plurality of spaced apartopenings 3904 extending along a central axis of the strip. The secondstrip 3906 illustrated in the lower portion of FIG. 36 may have aplurality of spaced apart notches 3908 extending from the upper andlower edges of the second strip and separate by a middle portion. Aplurality of the first strips 3902 and a plurality of the second strips3906 can be assembled into a stabilizing structure similar to what isshown in FIGS. 11A, 11C and 11D, wherein the plurality of first strips3902 are arranged in parallel to each other, and the plurality of secondstrips 3906 are arranged in parallel to each other. The plurality offirst 3902 and second strips 3906 engage one another by the middleportions 3910 of the second strips positioned through the openings 3904in the first strips, to place the plurality of first strips at an angleto the plurality of second strips. This structure is configured tocollapse in a horizontal plane while remaining rigid in the verticalplane.

FIG. 37 illustrates an embodiment of a stabilizing structure 4000similar to the embodiment of FIG. 16 described above. A plurality oflongitudinal strips 4002 can be provided each in the form of a wavystrip that, when joined face-to-face, form one or more circular or ovoidcells 4004. FIG. 38 illustrates another embodiment of a stabilizingstructure. In this embodiment, the stabilizing structure 4100 has anelongate, preferably oval shape, wherein cells 4102 within the ovalshape have a plurality of cells arranged in a plurality of concentricrings 4104. In the embodiment illustrated, a central oval cell issurrounded by two oval-shaped rings. Other embodiments can include morethan two oval-shaped rings.

Stabilizing Structures and Wound Closure Devices of FIGS. 39A-43

FIGS. 39A-F illustrate embodiments of a stabilizing structure 4200 thatare similar to the embodiments described above in relation to FIGS.32A-35. The stabilizing structure may comprise a plurality of elongatestrips 4202 arranged in parallel, whose longitudinal length can bealigned with the longitudinal axis when placed in a wound. Thestabilizing structure can further comprise a plurality of interveningmembers 4204 connected to the elongate strips 4202 via joints 4206. Incertain embodiments, the stabilizing structure 4200 can collapse in anymanner described in this section or elsewhere in this specification withor without the application of negative pressure. For example, thestabilizing structure may collapse significantly more in one plane thanin another plane. In some embodiments, the stabilizing structure can becomprised of any materials described in this section or elsewhere inthis specification, including: flexible plastics such as silicone,polyurethane, rigid plastics such as polyvinyl chloride, semi-rigidplastics, semi-flexible plastics, biocompatible materials, compositematerials, metals, and foam.

The stabilizing structure 4200 and all stabilizing structures and woundclosure devices described in this section or elsewhere in thisspecification can collapse on a variety of timescales in a dynamicfashion. As described elsewhere in the specification, the stabilizingstructures and/or wound closure devices may be incorporated as variousregions within a fabricated wound filler, thus the fabricated woundfiller can collapse in any manner described herein this section orelsewhere in the specification. In certain embodiments, the majority ofthe collapse may occur within the first few minutes upon application ofnegative pressure. However, after the initial collapse, the stabilizingstructure or wound closure device may continue to collapse at a muchslower rate, thereby applying increasing longitudinal tension over along period of time and drawing the edges of the wound closer together.By slowly drawing the wound edges closer together over time, thestabilizing structure or wound closure device allows the surroundinghealing tissue to remodel synergistically with the closure of the deviceor stabilizing structure. Slow, dynamic wound closure may allow thesurrounding tissue to heal at an accelerated rate, because thecollapsing structure or device slowly brings the edges of the woundcloser together without stressing the newly formed or weakened tissuetoo quickly.

In some embodiments, the stabilizing structures described in thissection or elsewhere in this specification can placed into a wound aspart of a fabricated wound filler for a period of time and then removedor replaced with another fabricated wound filler comprising astabilizing structure. For example, a fabricated wound filler comprisinga stabilizing structure could be inserted into a wound for a period oftime, promoting closure of the wound by drawing the edges closertogether. After a period of time has passed, the fabricated wound fillercomprising a stabilizing structure can be replaced by a fabricated woundfiller comprising a stabilizing structure of a different size orcollapsibility, for example a stabilizing structure of a smaller size ordecreased density. This process could be repeated over and over, therebycontinuously drawing the edges of the wound together over time andallowing for continuing repair and remodeling of the surrounding tissue.

In some embodiments, the stabilizing structure is configured to remainin the wound for at least about less than 1 hour, at least about 1 hour,at least about 2 hours, at least about 4 hours, at least about 6 hours,at least about 8 hours, at least about 12 hours, at least about 24hours, at least about 2 days, at least about 4 days, at least about 6days, at least about 1 week, at least about 2 weeks, at least about 3weeks, or more than 3 weeks.

In certain embodiments, up to 90% of the collapse of the stabilizingstructure or wound closure device may occur within the first few minutesupon application of negative pressure, while the remaining 10% of thecollapse may occur slowly over a period of many minutes, hours, days,weeks, or months. In other embodiments, up to about 80% of the collapse,up to about 70%, up to about 60%, up to about 50%, up to about 40%, upto about 30%, up to about 20%, up to about 10%, or about 0% of thecollapse will occur immediately within the first few minutes uponapplication of negative pressure while the remainder of the collapseoccurs at a much slower rate such as over the course of many minutes,hours, days weeks, or months. In other embodiments, the stabilizingstructure can collapse at a variable rate.

In some embodiments, the entirety of the collapse occurs at a slowedrate, while in other embodiments the entirety of the collapse occursalmost immediately within the first few minutes. In further embodiments,the collapse can occur at any rate and the rate can vary over time. Incertain embodiments, the rate of collapse can be altered in a variablefashion by adding and/or removing portions of the structure or bycontrolling the application of negative pressure and irrigant fluid.

As illustrated in the perspective view of FIG. 39A and the top view ofFIG. 39B, the intersection of the intervening members 4204 and theelongate strips 4202 may define a plurality of cells 4210. In certainembodiments, the cells 4210 may be of any of the shapes and sizesdescribed in this section or elsewhere in this specification, such asthose described in relation to FIGS. 32A-32C. For instance, a cell maybe in the shape of a square, a diamond, an oblong, an oval, and/or aparallelepiped.

The joints 4206 are configured to allow the intervening members 4204 tocollapse, similar to the joints described in FIGS. 32A-C and FIG. 34.The joints 4206 can be configured to allow the intervening members tocollapse in any manner as described in this section or elsewhere in thisspecification in relation to other embodiments, such as those describedin relation to FIGS. 32A-C. For example, the joints 4206 may beconfigured to allow or preferentially cause a first row of interveningmembers 4204 to collapse in one direction, while allowing orpreferentially causing an adjacent row to collapse in another direction.

The elongate strips 4202 may comprise alternating flexing segments 4212and supporting segments 4214. In a preferred embodiment, the flexingsegments 4212 can be constructed from a flexible or semi-flexiblematerial such as silicone and/or polyurethane. However, any flexible orsemi-flexible material may be suitable. The flexing segments 4212 canflex in any direction, allowing the stabilizing structure to collapsemore readily in any direction, but particularly in the horizontal plane.In a preferred embodiment, the supporting segments 4214 can beconstructed from a rigid or semi-rigid material such as polyvinylchloride (PVC). However, any rigid or semi-rigid material may besuitable. In the embodiment illustrated, the elongate strips 4202comprise elongate strips of a first material such as silicone and/orpolyurethane, with a plurality of elongate inserts of a second, morerigid material 4214 embedded into the first material. Thus, the flexingsegments 4212 are the areas in the elongate strips 4202 where the morerigid inserts are not located.

As illustrated in FIGS. 39A-D, the supporting segments 4214 may belarger than the flexing segments 4212. In one embodiment, the supportingsegments 4214 can be approximately three times as large as the flexingsegments 4212 (such as by spanning three cells 4210). In otherembodiments, the supporting segments 4214 may be the same size as theflexing segments 4212. In further embodiments, the flexing segments 4212can be larger than the supporting segments 4214. Alternatively, thelengths and widths of the individual segments of the elongate strips4202 can be variable. For example, the height of the supporting segments4214 can be reduced, such that they do not extend from approximately thetop to approximately the bottom of the stabilizing structure 4200. Insome embodiments a smaller supporting segment could encompassapproximately half the height of the elongate strip 4202. In certainembodiments, the supporting segment 4214 could be located in the upperor in the lower portion of the elongate strip. Such embodiments may beaccomplished by utilizing an insert of a second material that has asmaller height than the height of the first material forming theelongate strip 4202.

In some embodiments, the supporting segment does not alternate with theflexing segment 4212 and instead, the elongate strips 4202 are comprisedentirely of supporting segments 4214 (e.g., a silicone strip or othermaterial with an embedded more rigid insert extending the entire lengththereof, or simply a more rigid material by itself). Alternatively, theentirety of the elongate strip 4202 can be comprised only of flexingsegments 4212 (e.g., a strip made only of silicone or other moreflexible material).

In further embodiments, the supporting segments 4214 are insertableand/or removable from the elongate strips 4202, and may be insertedand/or removed to alter the collapsibility of the stabilizing structure4200. Supporting segments 4214 can be inserted and/or removed from thestabilizing structure 4200 after it has been placed in a wound tovariably control the collapse of the stabilizing structure 4200. In suchembodiments, the elongate strips 4202 may form pockets that are openfrom one side (e.g., from the top) to allow insertion and removal of thesupporting segments 4214.

FIGS. 39C-D illustrate in greater detail an embodiment of an individualsupporting segment 4214. The supporting member 4214 may be a flat,plate-like structure having a rectangular shape, with a length greaterthan its height, and two parallel surfaces. The supporting segment cancomprise at least one notch 4220, preferably located on the upper edgeof the supporting segment. In other embodiments, the notch or notchescan be located on the bottom or the sides of the supporting segment. Infurther embodiments, the top notch could have a corresponding bottomnotch. In certain embodiments, the notch could be configured so as toallow tearing of the supporting segment in a transecting line across thesupporting segment. The notch or notches 4220 may advantageously provideflexibility to the structure. The notches 4220 may allow the stabilizingstructure to flex more easily in the horizontal plane or in the verticalplane. The notches 4220 may further allow the stabilizing structure totwist in multiple planes. The notches 4220 may also improve fluid flowwithin the stabilizing structure 4200. In some embodiments, thesupporting segment does not contain a notch and the uppermost edge isflat. The notch 4220 can be located at other locations on the supportingsegment, for example the bottom edge or the sides. The shape of thenotch can be a rounded triangle as in FIGS. 39C-D or any other similarshape.

The intervening members 4204 in some embodiments may comprise a firstmaterial 4216 with an embedded insert 4218 made of a more rigidmaterial. One embodiment of the embedded insert is illustrated in FIGS.39E-F. In other embodiments, the first material 4216 may be in the formof a sleeve configured to receive the insert 4218. Further, the sleeve4216 may be configured to allow for the removal of an insert 4218, suchas by providing an opening in the top of the sleeve. In a preferredembodiment, the first material 4216 is constructed from a flexible orsemi-flexible material such as silicone and/or polyurethane. However,any flexible or semi-flexible material may be suitable. In a preferredembodiment, the insert 4218 is constructed from a rigid or semi-rigidmaterial such as polyvinyl chloride. However, any rigid or semi-rigidmaterial may be suitable.

FIG. 39E illustrates a front view of insert 4218, while FIG. 39Fillustrates a side view of insert 4218. The insert in one embodiment maybe a flat, plate-like structure having a rectangular shape, with aheight greater than its width, and two parallel surfaces. The insert cancomprise an indent 4222. The indent is preferably located at the upperportion of the insert, however, the indent 4222 can be positioned oneither side of the insert, or on the bottom. The indent 4222 can beconfigured such that it aids in allowing fluid to flow through thestabilizing structure by providing a flow path. The indent 4222 canimprove flexibility of the stabilizing structure 4200 and be configuredto allow for a more efficient collapse of the stabilizing structure4200.

In some embodiments, the stabilizing structure 4200 of FIGS. 39A-B canbe configured to include perforations or detachable sections that allowportions of the device to separate from the remainder of the device. Forexample, perforations may be incorporated into the joints 4206 betweenvarious cells contained within the stabilizing structure 4200, allowingfor the removal of individual rows or cells to alter the shape of thestabilizing structure 4200. In some embodiments, as described above inrelation to FIGS. 39C-D, the sections may be detached along perforationsor lines in the elongate strips corresponding to the notches 4220.

In some embodiments, the inserts 4218 may be entombed within firstmaterial 4216 in a variable number of intervening members 4204 tocontrol the shape and collapse of the stabilizing structure 4200. Inother embodiments, the inserts 4218 may be fabricated separately andinserted directly into sleeves comprised of first material 4216 withinthe intervening members 4204 to control the shape and collapse of thestabilizing structure 4200.

For example, the inserts 4218 can be present in at least about 5% of theintervening members, at least about 10% of the intervening members, atleast about 15% of the intervening members, at least about 20% of theintervening members, at least about 25% of the intervening members , atleast about 30% of the intervening members, at least about 35% of theintervening members, at least about 40% of the intervening members , atleast about 45% of the intervening members, at least about 50% of theintervening members, at least about 55% of the intervening members, atleast about 60% of the intervening members, at least about 65% of theintervening members, at least about 70% of the intervening members, atleast about 75% of the intervening members, at least about 80% of theintervening members, at least about 85% of the intervening members, atleast about 90% of the intervening members, at least about 95% of theintervening members, or about 100% of the intervening members.

In certain embodiments, a variable number of supporting segments 4214may be entombed within elongate strips 4202 to control thecollapsibility of the stabilizing structure 4200. In other embodiments,a variable number of supporting segments may be inserted into a pocketcontained within the elongate strips 4202 to control the collapsibilityof the stabilizing structure. For example, the supporting segments 4214can be present in at least about 5% of the total length of the elongatestrips, at least about 10%, at least about 15%, at least about 20%, atleast about 25%, at least about 30%, at least about 35%, at least about40%, at least about 45%, at least about 50% , at least about 55%, atleast about 60%, at least about 65%, at least about 70%, at least about75%, at least about 80%, at least about 85%, at least about 90%, atleast about 95%, or about 100% of the total length of the elongatestrips.

In certain embodiments, the inserts 4218 or supporting segments 4214 maybe inserted and/or removed over time to variably control the collapse ofthe stabilizing structure 4200. For example, although initially all theavailable sleeves 4216 of the stabilizing structure may contain aninsert, after the initial placement of the wound filler comprising astabilizing structure into a wound, additional inserts 4218 may beremoved over time, thus causing the stabilizing structure 4200 tocollapse even further. Inserts can also be added to the stabilizingstructure after it is inserted into a wound, thereby decreasing thecollapsibility of the stabilizing structure 4200. Thus, the additionand/or removal of the inserts 4216 or supporting segments 4214 allowsfor variable control of the collapse of the stabilizing structure 4200.In similar fashion, supporting segments 4214 can be inserted and removedfrom the elongated strips over time to provide variable control over thecollapse of the stabilizing structure 4200.

In certain embodiments of the stabilizing structures described in thissection or elsewhere in this specification, such as in stabilizingstructure 4200 as described in FIG. 39A, the flexibility of varioussections of the stabilizing structure is enhanced by thinning of thatsection. For example, in certain embodiments, rather than using aflexible material for a flexing segment 4212 of elongate strip 4202,instead the flexing segment 4212 can be constructed of a similarmaterial to that used to construct supporting segment 4214. In thisembodiment, since supporting segment 4212 is thicker than flexingsegment 4212 it will not flex to the degree of flexion that may beexperienced by flexing segment 4212. In certain embodiments, the entirestabilizing structure 4200 may be constructed from a single rigid orsemi-rigid material, but made to have different rigid and flexibleportions by thinning certain areas of the stabilizing structure 4200. Infurther embodiments, the joints 4206 may be thinned to allow for greaterflexibility as compared to the surrounding sections. In certainembodiments, thinning of a section of the stabilizing structure 4200,may allow the thinner portion to be more readily detached from thestructure.

As described above in relation to FIGS. 14A-19B and applicable to allstabilizing structures or wound closure devices described in thissection or elsewhere in the specification, a soft polymer could befabricated over the entire stabilizing structure 4200 to soften the feelof the device, thereby protecting the surrounding organs and/or othertissues. In other embodiments, the soft polymer could be fabricated onlyover the bottom portion of the stabilizing device 4200, while in someembodiments the softer polymer can be molded over the top and/or thesides of the device. In some embodiments, the soft polymer could befabricated over particular edges of the stabilizing structure 4200, suchas those on the bottom, sides, and/or top. In certain embodiments, thesoft polymer could be fabricated over any side or combination of sidesof the stabilizing structure 4200. The soft polymer may act like asoftened rim surrounding the hard edges of the stabilizing structure4200.

FIGS. 40A-D illustrate multiple views of another embodiment of thestabilizing structure 4200, similar to the stabilizing structuresdepicted in FIGS. 32A-C and 39A-E. As in the stabilizing structureembodiment depicted in FIGS. 39A-F, the stabilizing structure 4200comprises elongate strips 4202 and intervening members 4204. Theelongate strips 4202 may comprise openings 4224 configured to allow thepassage of fluid through the elongate strips 4202. To construct theopenings, holes or other shapes may fabricated directly through theelongate strips 4202. In the embodiment illustrated and as further shownin FIGS. 40C and 40D, the elongate strips 4202 further comprise morerigid inserts 4214 as described above. In such embodiments, the openings4224 may be fabricated through the rigid inserts 4214 in locations ofthe strip where the inserts are located, as well as through flexingsegments 4212 where the inserts are not located. The openings can beconfigured to evenly distribute fluid throughout the stabilizing deviceand/or direct fluid flow along a particular passage or direction. Inother embodiments, the intervening members comprise openings, similar tothe openings described in relation to the elongate strips.

FIGS. 41A-B illustrate embodiments of a stabilizing structure 4400, withfunctional and structural elements similar to the embodiments of thestabilizing structure depicted in FIGS. 39A-F. Similar to the otherstabilizing structures described previously, the stabilizing structure4400 comprises elongate strips 4402 and intervening members 4404. Theelongate strip 4402 may be a single unitary strip with no differingflexing segments or support segments. In certain embodiments, theelongate strip 4402 can be comprised entirely of rigid or semi-rigidmaterials such as polyvinyl chloride. In other embodiments, the elongatestrip 4402 may be comprised entirely of flexible or semi-flexiblematerial such as silicone and/or polyurethane. Similar to theembodiments described in FIGS. 39A-F, stabilizing structure 4400 maycollapse in any manner described in this section or elsewhere in thisspecification within any timescale described in this section orelsewhere in this specification. FIG. 41C depicts an embodiment of theelongate strips 4402 comprising openings 4416 to allow the passage offluid similar to the passage of fluid described in FIGS. 40A-E.

FIGS. 42A-B illustrate embodiments of stabilizing structure 4500 thatare similar to the stabilizing structures described above in relation toFIGS. 32A-35. Stabilizing structure 4500 comprises elongate strips 4502and intervening members 4504. Intervening members 4504 can furthercomprise windows 4506, configured to allow the passage of fluid. In someembodiments, all intervening members 4504 may comprise windows 4506,however in other embodiments only the horizontally outermost interveningmembers 4504 comprise windows 4506, while the inner intervening membersare similar to other embodiments described in this section or elsewherein this specification.

In certain embodiments, at least about 5% of the intervening memberscomprise windows, at least about 10%, at least about 15%, at least about20%, at least about 25%, at least about 30%, at least about 35%, atleast about 40%, at least about 45%, at least about 50%, at least about55%, at least about 60%, at least about 65%, at least about 70%, atleast about 75%, at least about 80%, at least about 85%, at least about90%, at least about 95%, or about 100% of the intervening members.

The elongate strip 4502 may further comprise a gap 4508, configured toallow the passage of fluid. The gap may extend nearly the entire lengthof the elongate strips 4502 or extend only a portion of the length ofthe elongate strip 4502.

FIG. 42B illustrates an embodiment of a stabilizing structure 4500,where the windows 4506 further comprise bars 4510. In certainembodiments, at least about 5% of the windows comprise bars, at leastabout 10%, at least about 15%, at least about 20%, at least about 25%,at least about 30%, at least about 35%, at least about 40%, at leastabout 45%, at least about 50%, at least about 55%, at least about 60%,at least about 65%, at least about 70%, at least about 75%, at leastabout 80%, at least about 85%, at least about 90%, at least about 95%,or about 100% of the windows.

FIGS. 43A-C are photographs of embodiments of stabilizing structure4200, similar to those embodiments of a stabilizing structure describedin relation to FIGS. 39A-42B, further comprising foam inserts 4800.Similar to the fabrication techniques described elsewhere in thespecification, the stabilizing structure and foam inserts may befabricated together via 3D fabrication techniques to form a region of awound filler such as those described in relation to FIGS. 2-4. Asdescribed previously, different types of structures and materials,including the stabilizing structures and wound closure devices describedherein this specification, may be fabricated as various regions of afabricated bespoke wound filler. The inserts 4800 may be constructedfrom any material described in this section or elsewhere in thisspecification, including flexible foams, semi-flexible foams, semi-rigidfoams, and rigid foams and other porous or compressible materials. Thestiffness of the foam inserts 4800 can be used to control the collapseof stabilizing structure 4200. For example, stiffer foams may impede thecollapse of the stabilizing structure 4200, while flexible foams mayallow the stabilizing structure to collapse more quickly and easily.Varying the flexibility/stiffness of the foams allows the structure tocollapse at any rate as described in this section or elsewhere in thisspecification. In some embodiments, the overall density of thestabilizing structure and/or wound closure device may be altered byincreasing or reducing the amount of foam within the structure 4200. Byreducing the overall density, the structure will be more readilycollapsible. Thus, the use of a lower density structure with less foammay allow for greater wound closure as such a structure is more readilycollapsible. Conversely, the use of a higher density structure with morefoam may be less collapsible. In other embodiments, the foam insertsonly comprise a portion of the individual cells 4210.

In some embodiments, the foams may be configured to degrade or dissolveover time, thereby allowing foam inserts to prop the stabilizingstructure open initially, before later degrading or dissolving in acontrolled manner to control the rate of collapse of the stabilizingstructure. In further embodiments, the foam inserts may be impregnatedwith biologically active materials that may promote wound healing. Forexample, the biologically active materials may be anti-inflammatorymolecules, growth factors, or anti-microbials.

FIG. 43A is a photographic perspective view of the stabilizing structure4200 in an open state whereby the cells 4210 that do not contain foamare not collapsed. FIG. 43B is a photographic of the top of stabilizingstructure 4200 wherein the cells 4210 are in a collapsed state. FIG. 43Cis a photograph of a top view of the stabilizing structure 4200 whereinsome of the rows have alternating cells filled with foam inserts 4800 orwithout foam inserts 4210. In some embodiments, the foam inserts can beinserted into at least about 5% of the cells, at least about 10%, atleast about 15%, at least about 20%, at least about 25%, at least about30%, at least about 35%, at least about 40%, at least about 45%, atleast about 50%, at least about 55%, at least about 60%, at least about65%, at least about 70%, at least about 75%, at least about 80%, atleast about 85%, at least about 90%, at least about 95%, or about 100%of cells.

The Wound fillers and Stabilizing Structures of FIGS. 44A-B

FIGS. 44A-B depict embodiments of a fabricated bespoke wound filler 5000comprising stabilizing structures, such as those described previously inthis specification, surrounded by a porous material 5004 such as foam.

In certain embodiments, the wound filler 5000 of FIGS. 44A-B maycomprise a series of cuts or perforations 5002..The wound filler may becomprised of a porous material 5004, such as those described herein thissection and elsewhere in this specification. The wound filler mayfurther comprise one or more stabilizing structures 5006, 5008 embeddedwithin the porous material 5004. The stabilizing structures may becompletely encased within the surrounding porous material 5004, suchthat the stabilizing structures are completely surrounded by the porousmaterial in all directions. In certain embodiments, portions of thestabilizing structures may protrude from the porous material. Forexample, the stabilizing structures may protrude from the top, bottom,or sides of the porous material.

As will be understood by one skilled in the art, the stabilizingstructures are not limited to a side by side arrangement in atwo-dimensional plane. Instead, with reference to the three-materialstructure embodiments described elsewhere, the stabilizing structuresmay also be arranged along the height of the structure in threedimensions.

In certain embodiments, the cuts or perforations 5002 in wound filler5000 through porous material 5004 may be of any type described hereinthis section or elsewhere in the specification, The cuts or perforationsmay allow frangible regions of the pad 5000 or three-dimensionalstructure to be detached so as to shape the wound filler orthree-dimensional structure to the shape of a wound. In certainembodiments, the stabilizing structures 5006 and 5008 are completelycontained within the detachable regions. In other embodiments, thestabilizing structures may extend between frangible regions, and thusthe stabilizing structures themselves may be separable. For example, thestabilizing structures may have cuts or perforations similar to thosecuts or perforations in the porous material 5004. In particularembodiments, the frangible stabilizing structures may not be surroundedby any porous material, instead they may be shaped to the shape of awound without the use of an encasing porous material. Further, any ofthe stabilizing structure embodiments described herein this section orelsewhere in the specification may be frangible and capable of beingshaped even in the absence of an encasing porous material. In certainembodiments, frangible regions of the stabilizing structure may beadhered to one another via an adhesive.

The stabilizing structures may be of a variety of shapes and sizes suchas those described herein this section or elsewhere in thespecification. Further, different types of stabilizing structures may beincorporated into a single wound filler 5000. For example, as depictedin FIG. 44A, the wound filler 5000 may be comprised of two types ofstabilizing structures, a smaller-celled stabilizing structure 5006, anda larger-celled stabilizing structure 5008. As illustrated in FIG. 44A,the larger-celled structure may be contained within the central portionof the wound filler 5000, while the smaller-celled stabilizing structurecan be contained throughout the outer regions. In certain embodiments,the larger-celled structures may be contained within the outer regionsof the wound filler 5000, while the smaller-celled structures may becontained within the central portions. The wound filler may besurrounded by a flexible annular outermost region 5010. In someembodiments, there may be additional similar regions, allowing forfurther frangible regions.

In particular embodiments, a portion of the wound filler containing onlyporous material may extend beyond the sections of the wound filler thatcomprise a stabilizing structure. This extending porous material-onlyportion of the wound filler may extend above, beneath or between layersof surrounding tissue, such as the skin, fatty tissue, fascia, muscle,or other suitable tissues. In some embodiments, this porousmaterial-only portion of the wound filler may extend for less than oneinch, at least 1 inch, at least 2 inches, at least 4 inches, at least 8inches, at least 12 inches, at least 15 inches, or more than 15 inches.

As depicted in FIG. 44B, the wound filler 5000 may be comprised oflarger-celled stabilizing structures 5008 within the central region andsurrounding regions, while the smaller-celled stabilizing structures5006 are contained only within the flexible outermost region 5010. Infurther embodiments, the wound filler may comprise more than two typesof stabilizing structures. For example, the wound filler may comprise atleast three types of stabilizing structures, at least four types ofstabilizing structures, at least five types of stabilizing structures,at least six types of stabilizing structures, or more than six types ofstabilizing structures. In certain embodiments, all of the stabilizingstructures are of the same type, i.e. have cells of the same size.

The stabilizing structures 5006, 5008 may be configured to collapse inany manner described herein this section or elsewhere in thespecification such as in relation to FIGS. 32A-34, 39A-42B, or 43A-C.Briefly, as described in detail elsewhere, the stabilizing structures5006 and 5008 can be configured to collapse more readily under negativepressure in a first direction, while not collapsing to a significantdegree in a second direction. Further, various stabilizing structuresmay have different collapsibility properties as described herein thissection or elsewhere in the specification.

In certain embodiments, the stabilizing structure may be of any typedescribed herein this section or elsewhere in this specification.Further, the stabilizing structure may be comprised of any of thematerials described herein this section or elsewhere in thespecification. In some embodiments, the wound fillers 5000 depicted inFIGS. 44A-B may be surrounded by an anchoring layer such as thosedescribed in relation to FIGS. 45. The anchoring layer may be attachedto the wound filler in any manner described herein this section orelsewhere in the specification. For example, the anchoring layer may beattached by an adhesive and/or via tape. In some embodiments, theanchoring layer may be fabricated directly as part of the wound fillervia 3D fabrication techniques.

In some embodiments, the wound filler 5000 may further comprise tissueanchors similar to those described in relation to FIGS. 45. The tissueanchors can be hooks, barbs, prongs, or other structures that serve toattach to the tissue of a wound. In some embodiments, the tissue anchorscomprise hook and loop fasteners such as those used in Velcrotechnologies. The anchors may extend from the stabilizing structures orfrom the foam portions of the wound filler.

The Anchoring Layer of FIG. 45

FIG. 45 illustrates an embodiment of an anchoring layer 4800 that maysurround the wound fillers described in this section or elsewhere inthis specification. As described above, the anchoring layer or ring canbe fabricated directly as part of the outside of the wound filler or maybe added separately. The ring 4800 can comprise a layer of tissueanchors 4802 configured to grip the surrounding edges of a wound. Forexample, the tissue anchors can be hooks, barbs, prongs, or otherstructures that serve to attach to the tissue of a wound. In certainembodiments, the tissue anchors comprise hook and loop fasteners such asthose used in Velcro technologies. In certain embodiments, the ring 4800can be comprised of foam, such as those described previously or the ringcan be comprised of a combination of a foam layer and a tissue anchorlayer 4802. A lip 4804 may extend inward from the ring 4800 and serve tooverlap the top and/or the bottom of a stabilizing structure asdescribed in this section or elsewhere in this specification, therebysecuring the ring 4800 around the stabilizing structure.

Applying the Bespoke Wound Filler

As is described herein this section and elsewhere in the specification,the bespoke wound filler may be applied to a wound in combination withother conventional wound healing related articles, such as a drape,vacuum source, foam, tubing, reservoir, bandage, adhesive, or any otherarticles suitable for the treatment of wound. In certain embodiments thebespoke wound filler may be combined with other wound fillers, such as abowl-shaped foam that may be placed underneath the wound filler asdescribed above. In some embodiments, these other wound healing articlesmay be constructed alongside the wound filler via suitable 3Dfabrication equipment. In certain embodiments, these other wound carearticles or components may be fabricated as attached to the bespokewound filler to form a wound treatment apparatus.

FIGS. 46A-B illustrate different views of a wound treatment apparatuscomprising a wound filler, similar to the wound treatment apparatusesand wound fillers described herein this section and elsewhere in thespecification. FIG. 46A illustrates a wound treatment apparatuscomprising a bespoke wound filler 401 as described herein this sectionand elsewhere in the specification. The wound treatment apparatusfurther comprises an opening 403, which may be connected to a source ofnegative pressure such as a suitable pump or other related structuressuch as a port or filter. One example of a suitable pump is the RenasysEZ pump available from Smith & Nephew. The apparatus may furthercomprise a flat sealed surface 405 that allows for sealing of the drape407. In some embodiments, the flat sealed surface immediately surroundsthe opening 403, such that the drape 407 can seal around the opening403. In certain embodiments, the flat sealed surface could be extendedto the wound edge or beyond and sealing strips applied as is describedin the PICO system available from Smith & Nephew. In some embodiments,the drape 407 may extend beyond the edges of the wound and may be sealedto the edges of the wound via any suitable means such as via anadhesive, or via sealing strips such as those disclosed above.

Similar to the apparatus described in FIG. 46A and elsewhere in thespecification, FIG. 46B illustrates a wound treatment apparatuscomprising a bespoke wound filler 401 as described herein this sectionand elsewhere in the specification. The wound treatment apparatusfurther comprises an opening 403, which may be connected to a source ofnegative pressure such as a suitable pump. The apparatus may furthercomprise a flat sealed surface 405 that allows for sealing of the drape407. The apparatus also comprises an integral port 409 to allow for easeof connection to a source of negative pressure. The port, as with all ofthe components described in relation to FIGS. 46A-B, may be fabricateddirectly via 3D fabrication techniques. In some embodiments, the bespokewound filler 401 is fabricated directly attached to the port 409.

In certain embodiments, to aid the clinician in the proper orientationof the bespoke wound filler, marks may be printed on the wound filler ordermis surface such that it allows the clinician to properly orient andplace the filler within the wound. These marks may be arrows, lines,words, or any other marking that will aid in placement of the filler. Incertain embodiments, anatomical terms or general terms may be used tomark the filler, for example, words such as “foot,” “head,” or “distal”may be used to direct the clinician in any desirable manner. In certainembodiments, marks are also made on the tissue surrounding the wound toallow for ease of orientation of the filler and wound treatment system

In some embodiments, the bespoke wound filler may be replaced multipletimes over the course of closure of a wound. The wound filler can bereplaced with another fabricated wound filler that may be better suitedto the wound at this later stage in the healing process. For example, awound filler inserted earlier in the healing process may comprisebioactive molecules that are primarily directed towards the earlyinflammatory stages of the host response to a wound while a later woundfiller may comprise bioactive molecules that are better suited to latterstage tissue repair. In other embodiments, wound fillers of variousshapes may be used at different stages of the wound healing process. Forexample, a larger wound filler could be used earlier in the healingprocess before much closure of the wound has occurred. At a later time,once the wound has closed to some degree, a smaller wound filler may beused as it may be better suited to the wound. The wound filler could bereplaced after at least about: 1 hour, 3 hours, 6 hours, 12 hours, 24hours, 2 days, 4 days, 7 days, 14 days, 21 days, 28 days, or more than28 days.

In some embodiments, the methods and apparatuses described above can beapplied to create a 3D model for a wound dressing that need not fill awound, but may be placed over a wound (such as with an incisionalwound). For example, a 3D model for an entire or portion of a wounddressing may be constructed having multiple layers, each with discreteproperties, such as described with respect to the multiple applicationsincorporated above regarding wound treatment apparatuses and methodsincorporating absorbent materials. The layers may be customized by themodel to optimize certain properties, such as absorbency, fluidtransfer, etc., based on the type, size and characteristics of the woundbeing treated and the treatment modality (e.g., negative pressure woundtherapy). The 3D printing methods or other techniques as described abovemay then be used to fabricate the wound dressing.

The Securing Mechanisms of FIGS. 48-49D

FIG. 48 illustrates an embodiment of a bespoke wound filler comprising alip 602 and multiple regions 604, 606, and 608, all printed integrallyas one wound filler. In certain embodiments, and as described elsewherein the specification, the bespoke wound filler may be printed with a lip602 around the periphery of the wound filler, to aid in securing thebespoke wound filler within the wound cavity. The lip may extendhorizontally out from the bespoke wound filler, to secure the woundfiller in place beneath a layer of tissue in an abdominal wound orelsewhere. For example, the lip may extend underneath the fascia orother tissue (represented here by “tissue”), thereby applying forcethrough the fascia to maintain the bespoke wound filler in place whilethe wound filler is pushed upward by the underlying abdominal organs. Incertain embodiments, the lip may comprise any material disclosed hereinthis section or elsewhere in the specification, for example, foam.Preferably, the lip is integral with the bespoke wound filler, meaningthat the lip is printed while the remainder of the wound filler isprinted. The lip may be constructed from the same materials as theremainder of the wound filler or the lip may be constructed from adifferent material.

The lip may comprise a variety of shapes and sizes, for example, the lip602 can have a length in some embodiments between 5 mm and 60 mm (orabout 5 mm and about 60 mm), for example 60 mm (or about 60 mm) or less,50 mm (or about 50 mm) or less, 40 mm (or about 40 mm) or less, 30 mm(or about 30 mm) or less, or 10 mm (or about 10 mm) or less. In certainembodiments, the lip may comprise tissue anchors such as any tissueanchor described herein this section or elsewhere in the specification.In some embodiments, the lip may comprise individual discrete fingersthat extend outward to secure the bespoke wound filler within the woundcavity.

FIG. 49A illustrates an embodiment of a securing portion 7004 that maybe printed integrally with the bespoke wound filler 6000 or may beprinted separately and attached to the bespoke wound filler 6000. Insome embodiments, the bespoke wound filler may be printed with securingportions 7004 that extend outward from the wound filler to aid insecuring the wound filler within the wound cavity, similar to the lipdescribed above in relation to FIG. 48. The securing portions will bedescribed in more detail below. Although embodiments of the securingportion are described in two formats: 1. a format where they are printedintegrally with the wound filler and 2. where the securing portions are3D printed separately to be later attached to a bespoke wound filler,all the embodiments described herein this section or elsewhere in thespecification may be printed integrally or separately from the bespokewound filler. As illustrated in FIG. 49A, in some embodiments, a 3Dprinter such as disclosed herein this section or elsewhere in thespecification may be used to construct a securing portion 7004 that canextend above or below tissue layers to aid in securing the bespoke woundfiller 6000 to the surrounding tissue. For example, when a bespoke woundfiller is placed into an abdominal wound, the underlying viscera maytend to expand and push the wound filler upwards and out of theabdominal wound. Such an occurrence is undesirable because, as describedelsewhere in the specification, in some embodiments the wound filler issuited to be placed within a wound whereby the wound filler canadvantageously draw the edges of the wound together. To alleviate theoutward pressure of the expanding viscera, in some embodiments asillustrated by FIG. 49A, before placing the stabilizing structure withinthe wound, the securing portion 7000 may be printed directly as part ofthe 3D wound filler to extend outward under 6000. The securing portion7004 of the bespoke wound filler 6000 may then extend outward from thestabilizing structure and under the surrounding tissue 7010, for examplethe fascia 7012.

In some embodiments, the securing portions are rigid, therefore once thesecuring portion 7004 is extended below the fascia 7012, the securingportion can absorb upward force from the swelling viscera whilemaintaining the bespoke wound filler 6000 in place within an abdominalor other type of wound. In further embodiments, the securing portion7004 may be semi-rigid or soft. In some embodiments, the securingportion can be made from any suitable material including, for example,plastics, ABS, PU, PE, PP, PET, silicone, Nylon, or other suitablematerials known in the art. Further, the securing portion can be made ofmetals including, for example, titanium, stainless steel, Inconel, orother suitable material known in the art. Additionally, the securingportion can be made of composites including, for example, carbon fiber,Kevlar, reinforced plastics, or other suitable material known in theart.

The securing portion may extend from the top or the bottom of the woundfiller, thereby extending the securing portion over the top or below thesurrounding tissue. In some embodiments, an anchoring layer such asthose described elsewhere in the specification, may be attached to thesecuring portion. One of skill in the art with recognize that such ananchoring layer may be applied to the securing portion in any suitablemanner, such as around or under the securing portion.

FIGS. 49B-D illustrates embodiments of stabilizing clips 7000, 7006, and7008, which comprise an attachment portion 7002, such that these clipsmay be 3D printed separately from the bespoke wound filler and attached(“clipped”) to the wound filler later. After attachment to the bespokewound filler, the securing portion 7004 of stabilizing clip 7000 extendsoutward to secure the bespoke wound filler within the wound cavity.Stabilizing clip 7000 may comprise an attachment portion 7002 thatallows the clip to attach to the underside or the top of a wound filler.In contrast, stabilizing clip 7006 may comprise an attachment portion7002 that loops over the top of a wall of a bespoke wound filler. Inthis way, the stabilizing clip 7006 will be more difficult to dislodgefrom the bespoke wound filler. Similar to stabilizing clip 7000described above, the stabilizing clip 7006 of FIG. 49C may comprise asecuring portion 7004 that extends below a layer of tissue such as thefascia, to maintain the wound filler in place. The securing portion 7004may extend from a lower end of the attachment portion 7002, however, inthis instance the lower end of the attachment portion is the open endbecause the stabilizing clip “clips” onto the stabilizing structure fromthe top.

FIG. 49D depicts another embodiment of a stabilizing clip 7008, similarto the stabilizing clip embodiments of FIGS. 49B-C. Stabilizing clip7008 has securing portions 7004, 7010 on both the upper and lowerportions of the stabilizing clip. The stabilizing clip may have a firstsecuring portion 7010 extending outward from an upper end of theattachment portion and a second securing portion 7004 extending outwardfrom a lower end of the attachment portion. Therefore, once attached toa bespoke wound filler, stabilizing clip 7008 may more tightly securethe bespoke wound filler in place because the securing portions extendboth above and below various tissue layers such as the fascia. Furtherexamples of lips, securing portions, and bespoke wound fillers may befound in PCT Patent Application PCT/US2014/025059, filed Mar. 12, 2014and published as WO 2014/165275, entitled NEGATIVE PRESSURE WOUNDCLOSURE DEVICE AND SYSTEMS AND METHODS OF USE IN TREATING WOUNDS WITHNEGATIVE PRESSURE, PCT Patent Application PCT/US2014/061627, filed Oct.12, 2014, entitled NEGATIVE PRESSURE WOUND CLOSURE DEVICE, and PCTPatent Application PCT/IB2013/002494, filed Aug. 8, 2013 and publishedas WO 2014/024048, entitled BESPOKE WOUND TREATMENT APPARATUSES ANDMETHODS FOR USE IN NEGATIVE PRESSURE WOUND THERAPY. The aforementionedapplications are hereby incorporated by reference in their entireties.

Features, materials, characteristics, or groups described in conjunctionwith a particular aspect, embodiment, or example are to be understood tobe applicable to any other aspect, embodiment or example describedherein unless incompatible therewith. All of the features disclosed inthis specification (including any accompanying claims, abstract anddrawings), and/or all of the steps of any method or process sodisclosed, may be combined in any combination, except combinations whereat least some of such features and/or steps are mutually exclusive. Theprotection is not restricted to the details of any foregoingembodiments. The protection extends to any novel one, or any novelcombination, of the features disclosed in this specification (includingany accompanying claims, abstract and drawings), or to any novel one, orany novel combination, of the steps of any method or process sodisclosed.

While certain embodiments have been described, these embodiments havebeen presented by way of example only, and are not intended to limit thescope of protection. Indeed, the novel methods and systems describedherein may be embodied in a variety of other forms. Furthermore, variousomissions, substitutions and changes in the form of the methods andsystems described herein may be made. Those skilled in the art willappreciate that in some embodiments, the actual steps taken in theprocesses illustrated and/or disclosed may differ from those shown inthe figures. Depending on the embodiment, certain of the steps describedabove may be removed, others may be added. Furthermore, the features andattributes of the specific embodiments disclosed above may be combinedin different ways to form additional embodiments, all of which fallwithin the scope of the present disclosure.

Although the present disclosure includes certain embodiments, examplesand applications, it will be understood by those skilled in the art thatthe present disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof, including embodiments which donot provide all of the features and advantages set forth herein.Accordingly, the scope of the present disclosure is not intended to belimited by the specific disclosures of preferred embodiments herein, andmay be defined by claims as presented herein or as presented in thefuture.

1-8. (canceled)
 9. A method of treating a wound, the method comprising:providing a bespoke tissue engaging apparatus fabricated from athree-dimensional model of an area to be treated, the bespoke tissueengaging apparatus comprising a plurality of identical repeatingsections configured to collapse in a manner determined by thethree-dimensional model to account for attributes of the area to betreated.
 10. The method of claim 9, wherein the bespoke tissue engagingapparatus is fabricated with a three-dimensional printer
 11. The methodof claim 9, wherein the bespoke tissue engaging apparatus comprises aporous material.
 12. The method of claim 9, wherein thethree-dimensional model of an area to be treated comprises repeatingblocks having different characteristics for positioning in differentparts of the area to be treated.
 13. The method of claim 9, wherein thearea to be treated comprises bone.
 14. The method of claim 9, whereinthe bespoke tissue engaging apparatus is fabricated from two or moredifferent materials.
 15. The method of claim 9, wherein the bespoketissue engaging apparatus comprises a plurality of elongate strips. 16.The method of claim 15, wherein the bespoke tissue engaging apparatuscomprises a plurality of intervening members connecting the elongatestrips, wherein the plurality of intervening members are configured topivot relative to the strips to allow the plurality of elongate stripsto collapse relative to one another.
 17. The method of claim 16, whereinthe intervening members between a first strip and a second strip areconfigured to pivot independently of the intervening members between asecond strip and a third strip
 18. The method of claim 9, wherein thebespoke tissue engaging apparatus comprises a polymer.
 19. The method ofclaim 9, wherein the bespoke tissue engaging apparatus is in the shapeof an oval.
 20. The method of claim 9, wherein the bespoke tissueengaging apparatus comprises tissue anchors, the tissue anchorsconfigured to engage tissue.
 21. The method of claim 16, wherein theplurality of intervening members between adjacent elongate strips definea row of cells between each pair of adjacent elongate strips.
 22. Themethod of claim 21, wherein the cells in a row between adjacent elongatestrips are configured to collapse together as the adjacent stripscollapse relative to one another.
 23. The method of claim 11, whereinthe bespoke tissue engaging apparatus comprises foam.
 24. A method ofdesigning a bespoke tissue engaging apparatus, the method comprising:obtaining a three-dimensional model of an area to be treated; andcreating a design for a bespoke tissue engaging apparatus, wherein thedesign is created using a plurality of identical repeating sections anduses the three-dimensional model to account for attributes of the woundto be treated and collapse of the design within the three-dimensionalmodel.
 25. The method of claim 24, wherein the bespoke tissue engagingapparatus comprises a porous material.
 26. The method of claim 25,wherein the porous material comprises foam.
 27. The method of claim 24,wherein the bespoke tissue engaging apparatus comprises two or moredifferent materials.
 28. The method of claim 24, wherein the bespoketissue engaging apparatus is configured to be fabricated with athree-dimensional printer.